Gabapentin Capsules — Class II drug recall D-0336-2015
Terminated recall by Actavis Elizabeth LLC, reported 2015-01-14, distributed in PR. Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of caps
| Recall number | D-0336-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Elizabeth LLC, Elizabeth, NJ, United States |
| Recall initiated | 2014-12-15 |
| Classified | 2015-01-08 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-11-20 |
| Distributed | PR |
| Quantity | 10,857 bottles |
| Reason classes | labeling |
| NDC | 14550-0513-02, 45963-0555, 45963-0555-11, 45963-0555-50, 45963-0556, 45963-0556-11, 45963-0556-50, 45963-0557, 45963-0557-11, 45963-0557-50 |
| Expiration dates | 2015-06, 2015-08 |
Product
Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, 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.
Reason for recall
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.
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-0336-2015. 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.