Bayer Chewable Low Dose Aspirin Recalled for Failed Stability Specifications
Bayer HealthCare Pharmaceuticals is recalling 104,128 bottles of Chewable Low Dose Aspirin 81 mg due to failed stability specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The failure of stability specifications without reported illness aligns with a moderate severity rating for a precautionary recall.
Plain-English summary
Bayer HealthCare Pharmaceuticals, Inc. is recalling 104,128 HDPE bottles of Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored. The product is identified by Lot # NAA3T0X and an expiration date of 07/18. The bottles were distributed nationwide.
The recall was initiated because the product failed stability specifications. The source text does not specify the exact nature of the stability failure or report any illnesses or injuries associated with the product.
Consumers with this product should stop using it and contact Bayer HealthCare Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
- Manufacturer
- Bayer HealthCare Pharmaceuticals, Inc.
- Category
- Drug — Aspirin
- Hazard
- Affected units
- 104,128
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 (2)
- Lot # NAA3T0X
- Exp. 07/18
Distribution
Distribution scope not specified by the agency.
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