FDA Drug recall D-0325-2021
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc…
- FDA Drug
- Class III
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class III recall of Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc… by Sun Pharmaceutical Industries, citing failed Moisture Limits: Out of specification for water content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0325-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-03-25 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, 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
Failed Moisture Limits: Out of specification for water content
Identifiers
| ndc | 62756-142-01 |
|---|---|
| ndc | 62756-142-02 |
| ndc | 62756-143-01 |
| code_info | Lot #JKU4639A, Exp 10/2022 |
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-0325-2021%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.