FDA Drug recall D-0109-2018
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)…
- FDA Drug
- Class II
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class II recall of 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)… by Sun Pharmaceutical Industries, citing microbial Contamination of Non-Sterile Products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0109-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-18 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Microbial Contamination of Non-Sterile Products
Identifiers
| ndc | 10631-238-01 |
|---|---|
| ndc | 10631-238-02 |
| ndc | 10631-206-01 |
| ndc | 10631-206-02 |
| code_info | A lot # 160031A, A160031B; Exp. 11/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Sun Pharmaceutical Industries recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0109-2018%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.