Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton

AUDIENCE: Consumer, Pharmacy

ISSUE: Bayer is voluntarily recalling Alka-Seltzer Plus packages that:

Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018.
Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

The affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton.

The ingredients listed on the front sticker of the carton may potentially be different from the ingredients listed on the back of the carton. This may lead consumers to ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their medical condition or they intend to otherwise avoid. There may be potential for serious health consequences.

BACKGROUND: The Alka-Seltzer Plus products subject to the recall are intended to temporarily relieve symptoms associated with cold and flu, such as cough, congestion, fever and/or mucus.

RECOMMENDATION: Consumers who purchased packages of Alka-Seltzer Plus that are being recalled should stop using the product and contact Bayer with questions, to report any issues experienced or for instructions about how to receive a refund.

Consumers with questions about this recall can contact Bayer Consumer Relations at: 1-800-986-0369 (available Monday - Friday 9:00 AM - 5:00 PM ET). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm601463.htm