[3/16/18] FDA is alerting consumers of a voluntary recall of Bayer’s Alka-Seltzer Plus products due to labeling errors.
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.
Consumers who purchased packages of Alka-Seltzer Plus that are being recalled should stop using the product immediately. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to using this drug product.
The affected packages are being recalled because the ingredients listed on the front sticker of the carton may be different from the ingredients listed on the back of the carton as well as the product in the carton. This may lead consumers to ingest an ingredient to which they are allergic to, or should not be taking, because of the potential for serious health consequences.
Consumers can contact Bayer at (800) 986-0369 with questions, to report any issues they experienced with the product or for instructions about how to receive a refund.
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.
FDA has not received any adverse event reports related to these recalled products.
Health care professionals and consumers should report any adverse events related to this product to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
- Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.