FDA Drug recall D-0014-2016
Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort L…
- FDA Drug
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort L… by Actavis Laboratories Fl, citing failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0014-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-25 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis Laboratories Fl |
| Distribution | US |
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
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Identifiers
| upc | 305912720603 |
|---|---|
| code_info | Lot: 1037736A, Exp 03/18 |
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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FDA Drug · Class III · 2015-08-12 · Actavis Laboratories Fl - Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Lab…
FDA Drug · Class III · 2015-04-22 · Actavis Laboratories Fl - Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only
FDA Drug · Class II · 2014-12-03 · Actavis Laboratories Fl - Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, In…
FDA Drug · Class II · 2014-10-08 · Actavis Laboratories Fl
All Actavis Laboratories Fl recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0014-2016%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.