Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-1305-2020
Terminated recall by AVKARE Inc., reported 2020-06-24, distributed nationwide. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake leve
| Recall number | D-1305-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2020-06-04 |
| Classified | 2020-06-12 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2022-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,586,913 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 42291-0610-10, 42291-0610-18, 42291-0610-36, 42291-0610-90, 50268-0531-15 |
| Expiration dates | 2020-06-30, 2020-07-31, 2020-08-31, 2020-09-30, 2020-10-31, 2020-11-30, 2021-01-31, 2021-03-31, 2021-04-30, 2021-05-31, 2021-06-30, 2021-07-31, 2021-08-31, 2021-10-31, 2021-11-30, 2022-01-31, 2022-02-28 |
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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-1305-2020. 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.