Metformin HCl Extended-Release Tablets — Class II drug recall D-0372-2021
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2021-05-19, distributed nationwide. Presence of foreign substance: identified as activated carbon.
| Recall number | D-0372-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-05-04 |
| Classified | 2021-05-07 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2023-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 50,868 bottles |
| NDC | 62756-0142, 62756-0142-01, 62756-0142-02, 62756-0143, 62756-0143-01 |
| Lot numbers | JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX2945A, JKX2946A, JKX2948A, JKX2952A, JKX2953A, JKX2954A, JKX3211A, JKX3212A, JKX3224A, JKX806A, JXK2947A |
| Expiration dates | 2023-07, 2032-06 |
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 for recall
Presence of foreign substance: identified as activated carbon.
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-0372-2021. 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.