RIOMET ER — Class II drug recall D-0002-2021
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2020-10-07, distributed nationwide. CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
| Recall number | D-0002-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2020-09-23 |
| Classified | 2020-10-01 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2021-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 747 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 10631-0019-17 |
| Lot numbers | AB06381 |
| Expiration dates | 2021-10 |
Product
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
Reason for recall
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
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-0002-2021. 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.