FDA Drug recall D-1386-2020
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), M…
- FDA Drug
- Class II
- ongoing
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), M… by Granules 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-1386-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-03 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Granules Pharmaceuticals |
| Distribution | US |
Product
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| ndc | 70010-491-01 |
|---|---|
| ndc | 70010-491-05 |
| ndc | 70010-491-10 |
| ndc | 70010-491-18 |
| ndc | 70010-491-19 |
| ndc | 70010-491-09 |
| ndc | 70010-492-01 |
| ndc | 70010-492-05 |
| ndc | 70010-492-20 |
| ndc | 70010-492-21 |
| code_info | a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 49…a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1386-2020%22
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