Riomet — Class II drug recall D-0334-2021
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2021-04-21, distributed nationwide. Microbial Contamination of Non-Sterile Product
| Recall number | D-0334-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-03-31 |
| Classified | 2021-04-13 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2022-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 13,834 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 10631-0206, 10631-0206-01, 10631-0206-02, 10631-0238, 10631-0238-01, 10631-0238-02 |
| Lot numbers | A200035A, B200064A, H200236A, J190386A, J190393A, X190354A |
| Expiration dates | 2021-03, 2021-05, 2021-06, 2021-08, 2022-01 |
Product
Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.
Reason for recall
Microbial Contamination of Non-Sterile 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-0334-2021. 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.