FDA Drug recall D-1383-2020
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 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, 90 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-1383-2020 |
| 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, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| ndc | 68180-338-01 |
|---|---|
| ndc | 68180-338-02 |
| ndc | 68180-338-03 |
| ndc | 68180-339-09 |
| ndc | 68180-339-01 |
| ndc | 68180-339-02 |
| code_info | Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-2…Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22 |
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-1383-2020%22
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