Metformin Hydrochloride Extended-Release Tablets USP — Class II drug recall D-1544-2020
Terminated recall by BAYSHORE PHARMACEUTICALS, reported 2020-09-02, distributed nationwide. CGMP Deviations
| Recall number | D-1544-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BAYSHORE PHARMACEUTICALS, Short Hills, NJ, United States |
| Recall initiated | 2020-08-19 |
| Classified | 2020-08-25 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,984 bottles |
| Reason classes | cgmp |
| NDC | 76385-0128, 76385-0128-01, 76385-0128-10, 76385-0128-50, 76385-0129, 76385-0129-01, 76385-0129-50 |
| Lot numbers | 18657 |
| Expiration dates | 2021-05 |
Product
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01
Reason for recall
CGMP Deviations
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-1544-2020. 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.