Aurobindo Recalls Famotidine 40mg Tablets Due to Foreign Tablet Presence
Aurobindo Pharma USA Inc. is recalling 1,296 bottles of Famotidine 40mg tablets because foreign tablets were found in the product.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of foreign tablets (including a different dose of the same drug and a different drug entirely) poses a significant risk of serious injury or death due to incorrect medication administration.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 1,296 bottles of Famotidine Tablets USP 40mg, 1,000-count bottles. The product is prescription-only and was distributed in Texas, California, Georgia, and Pennsylvania. The specific lot affected is P2000467, with an expiration date of 7/2022.
The recall was initiated because foreign tablets, specifically Famotidine 20mg and ibuprofen 400mg, were found in the lot of famotidine 40mg. This contamination presents a risk of patients receiving incorrect medication or dosages.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,296
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 #: P2000467
- Exp 7/2022
Distribution
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