Riomet — Class II drug recall D-0109-2018
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2017-12-20, distributed nationwide. Microbial Contamination of Non-Sterile Products
| Recall number | D-0109-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2017-04-18 |
| Classified | 2017-12-13 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2018-05-30 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| NDC | 10631-0206, 10631-0206-01, 10631-0206-02, 10631-0238, 10631-0238-01, 10631-0238-02 |
| Lot numbers | 11/17, 160031A, A160031B |
Product
Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512
Reason for recall
Microbial Contamination of Non-Sterile Products
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-0109-2018. 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.