Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-0014-2016
Terminated recall by Actavis Laboratories, FL, Inc., reported 2015-10-21, distributed nationwide. Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
| Recall number | D-0014-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Laboratories, FL, Inc., Davie, FL, United States |
| Recall initiated | 2015-09-25 |
| Classified | 2015-10-13 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2017-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 13,284 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00305912720603 |
| NDC | 00591-2720-60 |
| Lot numbers | 03/18, 1037736A |
Product
Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
Reason for recall
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
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-0014-2016. 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.