Metformin HCl Extended-Release Tablets — Class III drug recall D-0325-2021
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2021-04-14, distributed nationwide. Failed Moisture Limits: Out of specification for water content
| Recall number | D-0325-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-03-25 |
| Classified | 2021-04-07 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2022-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 2,520 bottles |
| Reason classes | specification failure |
| NDC | 62756-0142, 62756-0142-01, 62756-0142-02, 62756-0143, 62756-0143-01 |
| Lot numbers | JKU4639A |
| Expiration dates | 2022-10 |
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 for recall
Failed Moisture Limits: Out of specification for water content
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0325-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.