FDA Drug recall D-0337-2015
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt
- FDA Drug
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt by Actavis Elizabeth, citing failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0337-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-15 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis Elizabeth |
| Distribution | PR |
Product
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11
Reason
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Identifiers
| ndc | 59088-725-00 |
|---|---|
| ndc | 45963-556-11 |
| code_info | Lot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0337-2015%22
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