Famotidine Tablets — Class II drug recall D-0939-2023
Terminated recall by Glenmark Therapeutics, Inc., reported 2023-07-26, distributed nationwide. Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external lab
| Recall number | D-0939-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Therapeutics, Inc., Mahwah, NJ, United States |
| Recall initiated | 2023-05-01 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-07-26 |
| Terminated | 2024-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 19,968 bottles |
| Reason classes | labeling, potency |
| NDC | 72657-0112, 72657-0112-20, 72657-0112-90, 72657-0113, 72657-0113-20, 72657-0113-88, 72657-0132, 72657-0132-01 |
| Expiration dates | 2025-03 |
Product
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Reason for recall
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0939-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.