FDA Drug recall D-1334-2020
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Balti…
- FDA Drug
- Class II
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Balti… 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-1334-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-11 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)
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 # G901203, exp. date 12/2020 |
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-1334-2020%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.