FDA Drug recall D-0099-2019
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort L…
- FDA Drug
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort L… by Teva Pharmaceuticals Usa, citing defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0099-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-06 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Identifiers
| code_info | Lot #: 1210888A, Exp 03/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0099-2019%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.