Riomet — Class III drug recall D-0818-2018
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2018-05-23, distributed nationwide. Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified l
| Recall number | D-0818-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2018-04-26 |
| Classified | 2018-05-16 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2019-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 19,758 |
| Reason classes | labeling |
| NDC | 10631-0206, 10631-0206-01, 10631-0206-02, 10631-0238, 10631-0238-01, 10631-0238-02 |
| Lot numbers | E170210A, F170214A, F170223A, F170224A, F170231A, F170232A |
| Expiration dates | 2019-06-09, 2019-07-06, 2019-07-10, 2019-07-12, 2019-07-13 |
Product
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Reason for recall
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
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-0818-2018. 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.