FDA Drug recall D-0372-2021
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries,…
- FDA Drug
- Class II
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries,… by Sun Pharmaceutical Industries, citing presence of foreign substance: identified as activated carbon.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0372-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-04 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.
Reason
Presence of foreign substance: identified as activated carbon.
Identifiers
| ndc | 62756-142-01 |
|---|---|
| ndc | 62756-142-02 |
| ndc | 62756-143-01 |
| code_info | Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX…Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023. |
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-0372-2021%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.