FDA Drug recall D-1385-2020
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Man…
- FDA Drug
- Class II
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Man… by Lupin Pharmaceuticals, citing CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1385-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-07 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| ndc | 68180-336-07 |
|---|---|
| ndc | 68180-336-02 |
| ndc | 68180-336-01 |
| ndc | 68180-337-07 |
| ndc | 68180-337-01 |
| ndc | 68180-337-02 |
| code_info | Batch # G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-2…Batch # G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-20 G807618 Jul-20 G808042 Jul-20 G808043 Jul-20 G807349 Jul-20 G807350 Jul-20 G807444 Jul-20 G807507 Jul-20 G807508 Jul-20 G807314 Jul-20 G807316 Jul-20 G807325 Jul-20 G807348 Jul-20 G807616 Jul-20 G807312 Jul-20 G807313 Jul-20 G807315 Jul-20 G808374 Aug-20 G808427 Aug-20 G808373 Aug-20 G808426 Aug-20 G900057 Oct-20 G900058 Oct-20 G900059 Oct-20 G900060 Oct-20 G900061 Oct-20 G900062 Oct-20 G900106 Oct-20 G900140 Oct-20 G900141 Oct-20 G900152 Oct-20 G809596 Oct-20 G809598 Oct-20 G810182 Oct-20 G810183 Oct-20 G810184 Oct-20 G810185 Oct-20 G810186 Oct-20 G810187 Oct-20 G810188 Oct-20 G810189 Oct-20 G809554 Oct-20 G809556 Oct-20 G809557 Oct-20 G809558 Oct-20 G809559 Oct-20 G809548 Oct-20 G809549 Oct-20 G809550 Oct-20 G809551 Oct-20 G809552 Oct-20 G809553 Oct-20 G809555 Oct-20 G901004 Dec-20 G901005 Dec-20 G901053 Dec-20 |
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-1385-2020%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.