FDA Drug recall D-0098-2019
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort…
- FDA Drug
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort… 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-0098-2019 |
| 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
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
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 #: 1237868A, 1248900A, Exp 5/2020 |
|---|
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-0098-2019%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.