Famotidine tablets recalled for carton labeling error on strength
Glenmark Therapeutics is recalling famotidine 20 mg tablets after some cartons were labeled with a side label indicating 10 mg instead. The medication inside is correct; only the external carton label is mislabeled.
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: FDA Class II recall for a labeling error where an external side label on the carton incorrectly indicates strength. The product inside is correct; the error is limited to the external packaging label. No reported illnesses or injuries.
Plain-English summary
Glenmark Therapeutics, Inc. is recalling Famotidine Tablets, USP, 20 mg in 200-count bottles distributed nationwide in the United States. Some cartons labeled and containing 20 mg have an external label placed on the side of the carton indicating strength as 10 mg. This external label does not match the actual strength of the product inside.
The recall involves 19,968 bottles of the affected product. The affected cartons bear lot number FA2022001B with an expiration date of March 2025 (NDC 72657-113-20). This is classified as a Class II recall by the U.S. Food and Drug Administration.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Glenmark Therapeutics, Inc.
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 19,968
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)
- FA2022001B
- Exp 03/2025
UPCs (3)
- 0372657132015
- 0372657112901
- 0372657113885
Distribution
Distributed nationwide across the United States.
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