Recalls and Alerts: January 11, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Allergy Alert: D.F. Stauffer Biscuit Co., Inc. recalls Safeway Snack Artist Sugar Free Bite-Sized Chocolate Chip Cookies (10-oz clear plastic tubs; Lot #L07112B; Best By date of 07-11-12), due to the presence of undeclared eggs and milk. The recalled cookies were sold in Safeway, Carrs, Dominick’s, Genuardi’s, Pack ‘N Save, Pavillions, Randalls, Tom Thumb and Vons stores nationwide.
  • Food Safety Recall: Zip International Group LLC (Edison, NJ) recalls Sliced Herring – Forelka (330g and 600g plastic containers; Product of Ukraine; Best before 03/06/2012), due to Listeria monocytogenes contamination. The recalled product was sold in the New York Metropolitan Area.

Canada

  • Cosmetic Product Safety Recall: Himalaya USA recalls Organique Nourishing Night Cream (100mL pump cylinder; UPC 605069200196; Batch codes S691001 and S691002), due to contamination with Staphylococcus aureus and fungus in Batch #S691001. The recalled products were imported from the USA by Peak Performance Products Inc. (Etobicoke, ON) and sold in Canada from January 21, 2011 to January 3, 2012.

Europe

  • Allergy Alert (UK): Waitrose withdraws Waitrose Essential Salmon and Dill Fishcakes (170g; All date codes), due to the presence of low levels of mustard, which is not declared on the product label.
  • Food Safety Recall (Germany): METRO Cash & Carry recalls Tapas Trio Espanol, sliced (150g; Best before 01.02.2012 and thereafter), Chorizo sausage tapas Vela Loncheado sliced (80g and 200g; Best before 01.02.2012 and thereafter), Tapas Serrano ham, sliced (80g and 300g; Best before 01.02.2012 and thereafter) and Tapas Serrano Reserva (1/4 pcs (approx 1000g) and 1/2 pieces (approx 2200g); Best before 01.02.2012 and thereafter), due to contamination with Listeria monocytogenes. The recalled products were manufactured by Grupo Alimentario Argal SA Ctra (Spain) and were sold in METRO Cash & Carry stores.
  • Food Safety Notification (EU #2012.0047): Ochratoxin A in wheat snack from Poland; distributed to Poland.
  • Food Safety Notification (EU #2012.0049): Mercury in chilled swordfish from Spain; distributed to France.
  • Food Safety Notification (EU #2012.0050): Aflatoxins in maize from India; distributed to the United Kingdom.
  • Food Safety Notification (EU# 2012.0055): Listeria monocytogenes in mixed meat products from Spain; distributed to Belgium, Bulgaria, Germany, Greece, Hungary, the Netherlands, the Russian Federation, Slovakia and the United Kingdom.
  • Food Safety Notification (EU #2012.0056): Ochratoxin A in raisins from Germany; distributed to the Netherlands.
  • Food Safety Notification (EU #2012.0057): Ethephon in pineapple from Mauritius; distributed to the United Kingdom.
  • Food Safety Notification (EU #2012.0058): Salmonella in frozen hamburgers from Spain; distributed to Portugal.

Asia, Africa and the Pacific Islands

  • Outbreak Alert (Hong Kong): The Centre for Health Protection reports that seven institutional gastroenteritis outbreaks were recorded during the 1st week of January, up from two outbreaks the week before. The agency has issued letters to healthcare professionals and institutions to alert them to the seasonal peak of viral gastroenteritis and to remind them of appropriate measures to prevent the spread of the illness.

Australia and New Zealand

  • Outbreak Alert Update (Australia): The Department of Health reports that eggs are the suspected source of a Salmonella outbreak linked to Rizzo’s Pizza in Ballarat. At least 14 people are confirmed ill, including one person who later died. Five additional cases are still under investigation.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Recalls and Alerts: January 10, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Prescription Pharmaceutical Product Safety Alert: FDA and Endo Pharmaceuticals warn the public that certain Endo prescription products may have been subjected to a remote possibility of product mix-ups on the part of Endo’s contract manufacturer (Novartis Consumer Health, Inc.). Prescription tablets affected by this Alert include OPANA® ER Extended Release Tablets, OPANA® Tablets, Oxymorphone Hydrochloride Tablets, PERCOCET® Tablets, PERCODAN® Tablets, ENDOCET® Tablets, ENDODAN® Tablets, Morphine Sulfate Extended-Release Tablets, and ZYDONE® Tablets.
  • Food Withdrawal: Topco withdraws Spartan Fruit Pals Fruit Flavored Snacks – Assorted Fruit Flavors (5.4-oz box; Sell by 5/12/12 and 5/11/12), due to multiple complaints of hard pieces being reported in the Cherry flavored packs.
  • FDA Warning Letter: FDA warns Greencore OARS, LLC (Byfield, MA) that February/March 2011 and September/October 2011 inspections of the company’s ready-t0-eat sandwich manufacturing facility (Brockton, MA) revealed the presence of Listeria monocytogenes in environmental swabs and finished product samples.
  • FDA Warning Letter: FDA warns Jang Soo Farm, Inc. dba Rainier Sprouts (Tacoma, WA) that an August/September 2011 inspection of the company’s sprout growing facility revealed the presence and activity of rodents and insects, in addition to insanitary conditions and practices.
  • FDA Warning Letter: FDA warns Homeneeds, Inc. (Bothell, WA) that a June/July 2011 inspection of the company’s food storage and repacking facility (Woodinville, WA) revealed serious violations of FDA’s Current Good Manufacturing Practice regulation for manufacturing, packing, or holding human food.
  • FDA Warning Letter: FDA warns Gulfish, LP (Sausalito, CA) that a November 2011 inspection of the company’s seafood processing facility (San Francisco, CA) revealed serious violations of the seafood Hazard Analysis and Critical Control Point regulation.
  • FDA Warning Letter: FDA warns Li Da Seafood Trading, Inc. (Flushing, NY) that a November 2011 inspection of the company’s seafood processing facility revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and the Current Good Manufacturing Practice regulation for foods.

Europe

  • Food Safety Recall (UK): Makro recalls Tapas Chorizo Sliced (80g & 200g; bought after 6 October 2011), Tapas Serrano Ham Sliced (80g & 300g; bought after 6 October 2011) and Tapas Trio Sliced (150g; bought after 6 October 2011; contains Serrano ham, Chorizo sausage and Salchichol), due to possible contamination with Listeria monocytogenes.
  • Food Safety Recall (Greece): Makro Cash & Carry recalls Tapas Serrano Ham (1.5kg), Tapas Chorizo Sausage Sliced (80g & 200g), Tapas Ham Serrano Cons (80g & 300g) and Tapas Varieties Sausage slices (150g), due to possible contamination with Listeria monocytogenes.
  • Food Recall (Denmark): Dansk Supermarked Indkøb recalls ATCO hazelnut kernels (200g net wt; Best before 30.10.2012; Lot #L2384; Packaged in Germany) due to larvae infestation.
  • Food Recall (Denmark): Hedegaard Foods A/S recalls Pasteurized whole eggs in cups (4 cups, totaling 160g; Batch #H838; Best before 08.02.2012) due to a fishy odor and taste.
  • Contact Lens Recall (UK): Johnson & Johnson Vision Care recalls ACUVUE® OASYS® Brand Contact Lenses (8.8 Base Curve; -2.00D, -2.75D and -3.00D; Lot # L001RJ5, L001RJ8 and L001RJ9, respectively) following an isolated interruption in the lens rinsing process on one manufacturing line.
  • Food Safety Notification (EU #2012.0003): Campylobacter spp. in fresh spring onions from Thailand; distributed to Denmark.
  • Food Safety Notification (EU #2012.0004): Campylobacter spp. in red chili peppers from Vietnam; distributed to Denmark.
  • Food Safety Notification (EU #2012.0005): Listeria monocytogenes in chilled cooked shrimps from Spain; distributed to France, Italy, Portugal and Spain.
  • Food Safety Notification (EU #2012.0008): Salmonella typhimurium in chilled smoked bacon from France; distributed to Italy, Portugal and Spain.
  • Allergy Alert Notification (EU #2012.0015): Undeclared gluten in gluten-free baby porridge from Poland; distributed to Austria, Azerbaijan, Croatia, Germany, Hungary and Slovenia.
  • Food Safety Notification (EU #2012.0016): Listeria monocytogenes in smoked salmon from the United Kingdom; distributed to Switzerland.
  • Food Safety Notification (EU #2012.0023): High aluminium content in vermicelli noodles from China, via the Netherlands; distributed to Germany.
  • Food Safety Notification (EU #2012.0029): Mercury in sliced frozen blue shark manufactured in Italy, with raw material from Vietnam; distributed to Italy.
  • Food Safety Notification (EU #2012.0037): Aflatoxins in groundnut cakes (Kuli-kuli) from Nigeria; distributed to the United Kingdom.
  • Food Safety Notification (EU #2012.0038): Aflatoxins in white maize from Nigeria; distributed to the United Kingdom.
  • Allergy Alert Notification (EU #2012.0039): Undeclared mustard and celery in chilled cheese product from the Netherlands; distributed to Germany and the Netherlands.
  • Food Safety Notification (EU #2012.0040): Anisakis infestation of frozen horse mackerel from Spain, via Bulgaria; distributed to Romania.

Asia, Africa and the Pacific Islands

  • Food Safety Enforcement Action (Abu Dhabi): The Abu Dhabi Food Control Authority has seized Vimto Fruit Drink (250mL bottles) from retail outlets after the product was determined to be contaminated. The nature of the contamination was not specified.
  • Food Safety Alert (India): A survey of milk samples carried out by the Food Safety and Standards Authority of India has revealed that more than two-thirds of the milk samples tested contained adulterants, including water, skim milk powder, glucose and detergents.

Australia and New Zealand

  • Personal Care Product Safety Recall (Australia): Nouveau Smiles Pty Ltd recalls BDazzled Teeth Whitening System for home use, because the product contains an excessive concentration of hydrogen peroxide. The recalled product was sold nationally.
  • Outbreak Alert (Australia): Health officials have shut down a restaurant in Ballarat, VIC as part of an investigation into a suspected Salmonella outbreak linked to the restaurant. The Health Department has confirmed 13 cases of Salmonella; five additional cases are still under investigation. One death also is being investigated and may be linked to the same outbreak.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Novartis Gives Consumers Excedrin Headache

“Your Quality Unit has failed in the responsibility and authority to monitor Quality Systems designed to assure the quality of drug products manufactured and packaged at your firm.”

FDA to Novartis Consumer Health (Lincoln, Nebraska), July 8, 2011

On July 8, 2011, FDA completed an inspection of Novartis Consumer Health (Lincoln, Nebraska), and handed the company a report (Form 483) listing 13 separate “Observations” relating to deficiencies in Novartis’ quality assurance and complaint handling systems.

About one month later, Giant® Food Stores notified its customers that Novartis had recalled Excedrin Extra Strength Caplets, 100-count (Lot #10068948; Expiration date March 31, 2010), “as a result of instances of product mix-ups found in the lot” (posted on eFoodAlert September 7, 2011).

On November 1, 2011, Giant® Food Stores warned its customers of another Novartis recall – Excedrin – Pain Reliever Acetaminophen Adult, 100 CO (Lot #10087530; Expiration date 3/31/2013). Again, the recall was due to product mix-up occurrences in the lot. That same day, Food City posted a recall notice for three Novartis products, including Excedrin Extra Strength Caplets 24 countExcedrin Migraine Caplets 24 count, and Excedrin Floorstand ES Migraine with $1 IRC. More retailers chimed in the following day, and a consolidated list of recalled lots was provided on eFoodAlert’s Recalls and Alerts: November 2, 2011.

Today (January 8, 2012), in an unusual Sunday announcement, Novartis Consumer Health, Inc. issued a News Release detailing the recall of “…all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.”

Am I being silly, or is it just possible that FDA’s posting on January 5th of the July 8, 2011 Novartis Inspectional “Observations” Report might be somehow tied into this sudden decision by Novartis to go public?

Here are just a few excerpts from the report. These are direct quotations. Read them and decide for yourself.

  • You have failed to open deviation investigations into numerous “critical” consumer complaints of foreign products found inside the drug products manufactured at your firm.
  • You have failed to adequately investigate 166 complaint instances of foreign tablets in your drug products since 2009.
  • You have failed to extend investigations to all batches of product potentially affected by a problem.
  • You have received numerous consumer complaints which were not submitted to the FDA as required by your firm’s procedures.
  • Your Quality Assurance review of critical foreign tablet complaint investigations (Technical Complaint Investigation Reports) is not occurring in a timely manner… There are approximately 138 reports that took over 100 days to review.
  • You have failed to identify the root cause of customer complaints for solid dosage form foreign tablets of products manufactured at your firm since at least 2009.
  • Your Unplanned Deviation Reports are deficient in that conclusions drawn are not supported by the evidence in the reports.
  • Your Quality Assurance Unit has consistently failed to review critical complaints for drug products manufactured and packaged at your facility. For example [for 2011], 223 critical complaints have not been properly reviewed out of 223 critical complaints received by your firm… Also, your Quality Assurance review of critical complaints ceased in mid-October 2010. This deficiency was unnoticed by your Quality Unit until this FDA inspection.

The entire report is 13 pages long. It details lapses in procedure, in judgment, and in training.

In addition to the recall, Novartis advises that its Lincoln, NE facility “…has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.”

I have to ask – WHAT TOOK SO LONG?

Novartis has promised to have a dedicated web page (www.novartisOTC.com) in operation by January 9th to provide consumers with detailed information on its newly announced recall. The complete list of recalled products follows:

  • Bufferin® Extra Strength Tablets 130CT: UPC 300672065131
  • Bufferin® Extra Strength Tablets 39CT: UPC 300672065391
  • Bufferin® Low Dose Tablets 130CT: UPC 300676424132
  • Bufferin® Regular Strength Tablets 130CT: UPC 300672063137
  • Excedrin® Back & Body Caplets 100CT Account Specific: UPC
  • 300676238920
  • Excedrin® Back & Body Caplets 100CT Account Specific No Carton: UPC 300676238944
  • Excedrin® Back & Body Caplets 100CT New Label: UPC 300676238913
  • Excedrin® Back & Body Caplets 24CT New Label: UPC
  • 300676238241
  • Excedrin® Back & Body Caplets 50CT New Label: UPC
  • 300676238500
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000927
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000910
  • Excedrin® Extra Strength Caplets 100CT: UPC 300672000910
  • Excedrin® Extra Strength Caplets 125CT Bonus Pack: UPC 300672000835
  • Excedrin® Extra Strength Caplets 125CT Bonus Pack Account Specific: UPC 300672000842
  • Excedrin® Extra Strength Caplets 125CT New Carton: UPC 300672000866
  • Excedrin® Extra Strength Caplets 24+6CT Bonus Pack: UPC 300672000309
  • Excedrin® Extra Strength Caplets 24CT: UPC 300672000248
  • Excedrin® Extra Strength Caplets 24CT New Label: UPC 300672000248
  • Excedrin® Extra Strength Caplets 250CT No Carton: UPC 300672000071
  • Excedrin® Extra Strength Caplets 250CT No Carton New Label: UPC 300672000071
  • Excedrin® Extra Strength Caplets 250CT Special Inner: UPC 300672000774
  • Excedrin® Extra Strength Caplets 250CT New Label: UPC 300672000774
  • Excedrin® Extra Strength Caplets 300CT Bonus Pack: UPC 300672000552
  • Excedrin® Extra Strength Caplets 50CT New Label: UPC 300672000507
  • Excedrin® Extra Strength Caplets 50S: UPC 300672000507
  • Excedrin® Extra Strength Express Gel Caps 20CT New Label: UPC 300676270203
  • Excedrin® Extra Strength Express Gel Caps 40CT New Label: UPC 300676270401
  • Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270814
  • Excedrin® Extra Strength Express Gel Caps 80CT: UPC 300676270807
  • Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270944
  • Excedrin® Extra Strength Gel Tablets 24CT: UPC 300672021243
  • Excedrin® Extra Strength Tablets 100CT Special Inner: UPC
  • 300672030917
  • Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030931
  • Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030948
  • Excedrin® Extra Strength Tablets 100CT New Label: UPC 300672030917
  • Excedrin® Extra Strength Tablets 125CT Bonus Pack: UPC 300672030832
  • Excedrin® Extra Strength Tablets 125CT Bonus Pack New Carton: UPC 300672030863
  • Excedrin® Extra Strength Tablets 200CT New Label: UPC 300672030924
  • Excedrin® Extra Strength Tablets 24+6CT Bonus Pack: UPC 300672030306
  • Excedrin® Extra Strength Tablets 24CT: UPC 300672030245
  • Excedrin® Extra Strength Tablets 24CT New Label: UPC 300672030245
  • Excedrin® Extra Strength Tablets 250+50CT Bonus Pack: UPC 300672030573
  • Excedrin® Extra Strength Tablets 250CT No Carton: UPC 300672030078
  • Excedrin® Extra Strength Tablets 250CT No Carton New Label: UPC 300672030078
  • Excedrin® Extra Strength Tablets 250CT Special Inners: UPC 300672030771
  • Excedrin® Extra Strength Tablets 250CT New Label: UPC 300672030771
  • Excedrin® Extra Strength Tablets 300CT New Carton: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300CT Club Tray: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300CT New Label: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300S: UPC 300672030337
  • Excedrin® Extra Strength Tablets 50CT: UPC 300672030504
  • Excedrin® Extra Strength Tablets 50CT New Label: UPC 300672030504
  • Excedrin® Extra Strength Tablets 8CT: UPC 300672030085
  • Excedrin® Extra Strength Tablets 8CT New Label: UPC 300672030085
  • Excedrin® Migraine Express Gel Caplets 20CT New Label: UPC 300676341200
  • Excedrin® Migraine Caplets 100CT: UPC 300672039910
  • Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672039941
  • Excedrin® Migraine Caplets 100CT Account Specific No Carton: UPC 300672039941
  • Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672043917
  • Excedrin® Migraine Caplets 100CT New Label: UPC 300672039910
  • Excedrin® Migraine Caplets 125CT Bonus Pack No Carton: UPC 300672039842
  • Excedrin® Migraine Caplets 125CT Bonus Pack New Carton: UPC 300672039866
  • Excedrin® Migraine Caplets 125CT Bonus Pack: UPC 300672039835
  • Excedrin® Migraine Caplets 200CT New Label: UPC 300672039927
  • Excedrin® Migraine Caplets 24+6CT Bonus Pack: UPC 300672039309
  • Excedrin® Migraine Caplets 24CT: UPC 300672039248
  • Excedrin® Migraine Caplets 24CT New Label: UPC 300672039248
  • Excedrin® Migraine Caplets 250+50CT Bonus Pack: UPC 300672039576
  • Excedrin® Migraine Caplets 250CT No Carton: UPC 300672039071
  • Excedrin® Migraine Caplets 250CT No Carton New Label: UPC 300672039071
  • Excedrin® Migraine Caplets 250CT Special Inners: UPC 300672039774
  • Excedrin® Migraine Caplets 250CT New Label: UPC 300672039774
  • Excedrin® Migraine Caplets 300CT: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT New Carton: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT New Label: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT Club Tray: UPC 300672039330
  • Excedrin® Migraine Caplets 50CT New Label: UPC 300672039507
  • Excedrin® Migraine Caplets 50CT: UPC 300672039507
  • Excedrin® Migraine Caplets 8CT New Label: UPC 300672039088
  • Excedrin® Migraine Gel Tablets 160CT: UPC 300672035165
  • Excedrin® Migraine Gel Tablets 100CT Special Inner: UPC 300672035912
  • Excedrin® Migraine Gel Tablets 100CT New Label: UPC 300672035912
  • Excedrin® Migraine Gel Tablets 100CT Account Specific: UPC 300672044914
  • Excedrin® Migraine Gel Tablets 24CT – New Label: UPC 300672035240
  • Excedrin® Migraine Gel Tablets 2X50CT: UPC 300672035936
  • Excedrin® Migraine Gel Tablets 50CT New Label: UPC 300672035509
  • Excedrin® Migraine Tablets 100CT Special Inner: UPC 300672037916
  • Excedrin® Migraine Tablets 100CT New Label: UPC 300672037916
  • Excedrin® Migraine Tablets 125CT Bonus Pack: UPC 300672037831
  • Excedrin® Migraine Tablets 24+6CT Bonus Pack: UPC 300672037305
  • Excedrin® Migraine Tablets 24CT: UPC 300672037244
  • Excedrin® Migraine Tablets 24CT New Label: UPC 300672037244
  • Excedrin® Migraine Tablets 250CT Special Inner: UPC 300672037770
  • Excedrin® Migraine Tablets 250CT New Label: UPC 300672037770
  • Excedrin® Migraine Tablets 50CT: UPC 300672037503
  • Excedrin® Migraine Tablets 50CT New Label: UPC 300672037503
  • Excedrin® PM Caplets 100CT New Label: UPC 300672055910
  • Excedrin® PM Caplets 125CT Bonus Pack New Carton: UPC 300672055866
  • Excedrin® PM Caplets 24CT New Label: UPC 300672055248
  • Excedrin® PM Caplets 50CT New Label: UPC 300672055507
  • Excedrin® PM Express Gel Caplets 20CT: UPC 300676405209
  • Excedrin® PM Express Gel Caplets 80CT Account Specific: UPC 300676405810
  • Excedrin® PM Express Gel Caplets 80CT No Carton: UPC 300676409801
  • Excedrin® PM Express Gel Caplets 80CT New Label: UPC 300676405803
  • Excedrin® PM Tablets 100CT Account Specific: UPC 300672053923
  • Excedrin® PM Tablets 100CT Account Specific No Carton: UPC 300672053947
  • Excedrin® PM Tablets 100CT New Label: UPC 300672053916
  • Excedrin® PM Tablets 125CT Bonus Pack: UPC 300672053831
  • Excedrin® PM Tablets 24+6CT Bonus Pack: UPC 300672053305
  • Excedrin® PM Tablets 24CT New Label: UPC 300672053244
  • Excedrin® PM Tablets 50CT New Label: UPC 300672053503
  • Excedrin® PM Tablets 8CT New Label: UPC 300672053084
  • Excedrin® Sinus Headache Caplets 24CT New Label: UPC 300672062246
  • Excedrin® Tension Headache Caplets 100CT Special Inner: UPC 300672045911
  • Excedrin® Tension Headache Caplets 100CT Account Specific No Carton: UPC 300672045942
  • Excedrin® Tension Headache Caplets 100CT Account Specific No Carton New Label: UPC 300672045942
  • Excedrin® Tension Headache Caplets 100CT Account Specific: UPC 300672045959
  • Excedrin® Tension Headache Caplets 100CT New Label: UPC 300672045911
  • Excedrin® Tension Headache Caplets 125CT Bonus Pack: UPC 300672045836
  • Excedrin® Tension Headache Caplets 125CT Bonus Pack No Carton: UPC 300672045843
  • Excedrin® Tension Headache Caplets 24+6CT Bonus Pack: UPC 300672045300
  • Excedrin® Tension Headache Caplets 24CT Special Inner: UPC 300672045249
  • Excedrin® Tension Headache Caplets 24CT New Label: UPC 300672045249
  • Excedrin® Tension Headache Caplets 250CT: UPC 300672045775
  • Excedrin® Tension Headache Caplets 250CT No Carton: UPC 300672045072
  • Excedrin® Tension Headache Caplets 50CT Special Inner: UPC 300672045508
  • Excedrin® Tension Headache Caplets 50CT New Label: UPC 300672045508
  • Excedrin® Tension Headache Express Gel Caplets 20CT: UPC 300676272207
  • Excedrin® Tension Headache Express Gel Caplets 40CT: UPC 300676272405
  • Excedrin® Tension Headache Express Gel Caplets 80CT Account Specific: UPC 300676272948
  • Excedrin® Tension Headache Express Gel Caplets 80CT: UPC 300676272801
  • Excedrin® Tension Headache Gel Tablets 24CT New Label: UPC 300672050243
  • Gas-X® Prevention® Caplets 20CT: UPC 300433005208
  • Gas-X® Prevention® Caplets 50CT: UPC 300433005505
  • NoDoz® Maximum Strength Caplets 16CT: UPC 300672070166
  • NoDoz® Maximum Strength Caplets 16CT New Graphic: UPC 300672070166
  • NoDoz® Maximum Strength Caplets 36CT: UPC 300672070364
  • NoDoz® Maximum Strength Caplets 36CT New Graphic: UPC
  • 300672070364
  • NoDoz® Maximum Strength Caplets 60CT: UPC 300672070609
  • NoDoz® Maximum Strength Caplets 60CT New Graphic: UPC 300672070609

The recall encompasses all production lots of these products distributed in the USA. In addition, two of the recalled products – Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets – were exported to Canada. Following is a list of retail supermarkets and pharmacies in the USA and Canada who stocked the recalled products (updated January 17, 2012):

  • Acme: Excedrin, Bufferin, NoDoz & Gas-X Prevention
  • Albertsons: Excedrin, Bufferin, NoDoz & Gas-X Prevention
  • Big Y: Excedrin and Gas-X
  • Buehler’s Fresh Foods: Excedrin, Bufferin, GasX and NoDoz
  • Copps: All lot codes of Excedrin, Bufferin, No-Doze and Gas-X Prevention
  • Costco: Excedrin products (Costco Item ##720393,#672030, #146557, #618236, and #6189) sold on or after January 8, 2009
  • Costco Canada: Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets (All expiration dates up to and including December 20, 2014)
  • D&W Fresh Market: Bufferin and Excedrin products
  • Family Fare Supermarkets: Bufferin and Excedrin products
  • Food City: Assorted Excedrin, No Doz, Bufferin & Gas-X Items
  • Giant Eagle: Bufferin, Excedrin, Gas-X and NoDoz
  • Giant® Food Stores: Excedrin, Bufferin, No Doz & Gas-X
  • The Kroger Company (including Kroger, King Soopers, City Market, Jay C, Dillons, Baker’s Gerbes, Fry’s, Food4Less, Food4Less Fremont, FoodsCo, Ralphs, Fred Meyer, Smith’s and QFC stores): Bufferin, Excedrin, No Doz and Gas-X
  • Glen’s: Bufferin and Excedrin products
  • Glen’s Fresh Market: Bufferin and Excedrin products
  • H-E-B: Bufferin, Excedrin, Gas-X Prevention and NoDoz
  • Mariano’s Fresh Market: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Metro Market: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Pick ‘n Save: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Price Chopper: Excedrin, Bufferin, GasX, No Doz
  • Publix: Excedrin, Gas-X, Bufferin and No-Doz
  • Rainbow: All lots of Excedrin, Bufferin, No-Doze, Gas-X
  • Rite Aid: Bufferin, Excedrin, Gas-X Prevention and NoDoz products
  • Schnucks: (including Schnucks, Logli and Hilander stores): Excedrin, Bufferin, NoDoz and Gas-X Prevention
  • ShopRite: Bufferin, Excedrin, NoDoz and Gas-X Prevention products
  • Spartan: Bufferin and Excedrin products
  • Target: Excedrin and Gas-X Prevention products
  • Top Food & Drug: Excedrin and Bufferin products
  • Valu Land: Bufferin and Excedrin products
  • VG’s Fresh Market: Bufferin and Excedrin products
  • VG’s Grocery: Bufferin and Excedrin products
  • Walgreens: Provides link to recall notice on FDA site
  • Walmart (including Walmart and Sam’s Club stores): Excedrin, N0Doz, Bufferin and Gas-X Prevention products
  • Wegmans: Bufferin, Excedrin, Gas-X Prevention and NoDoz products