Bayer Recalls Alka-Seltzer Tablets Due to Defective Blister Pack Foil
Bayer HealthCare is recalling Alka-Seltzer Original effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a packaging defect (holes/cracks in foil) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Bayer HealthCare Pharmaceuticals, Inc. is recalling 1,067,520 12-count cartons of Alka-Seltzer Original effervescent tablets. The product is distributed nationwide and is made in Germany. The recall involves specific lot codes with expiration dates ranging from February 2019 to August 2019.
The recall was initiated due to confirmed customer complaints regarding small holes or cracks in the foil of the blister packs. This defect in the container packaging is the stated reason for the action.
Consumers with these products should stop using them and contact Bayer HealthCare for further instructions or a refund. The affected product is identified by the UPC 016500040194 and the specific lot codes listed in the recall notice.
The recalled product
- Product
- Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
- Manufacturer
- Bayer HealthCare Pharmaceuticals, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- BTAH340
- Exp. 02/19 BTAHCP0
- Exp. 04/19 BTAHLW0
- Exp. 06/19 BTAHLX0
- Exp. 08/19 BTAHP10
- Exp 08/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Bayer HealthCare Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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