FDA Drug recall D-0939-2023
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in…
- FDA Drug
- Class II
- terminated
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in… by Glenmark Therapeutics, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0939-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-05-01 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Therapeutics |
| Distribution | US |
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
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.
Identifiers
| ndc | 72657-112-90 |
|---|---|
| ndc | 72657-112-20 |
| ndc | 72657-113-88 |
| ndc | 72657-113-20 |
| ndc | 72657-132-01 |
| code_info | FA2022001B, Exp 03/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0939-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.