FDA Drug recall D-0002-2021
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz
- FDA Drug
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz by Sun Pharmaceutical Industries, citing CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0002-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-23 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Identifiers
| code_info | Lot #: AB06381; Exp 10/2021 |
|---|
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-0002-2021%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.