Gabapentin Tablets USP — Class III drug recall D-1272-2020
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2020-05-27, distributed nationwide. Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability t
| Recall number | D-1272-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Hauppauge, NY, United States |
| Recall initiated | 2020-05-14 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 2,202 bottles |
| Reason classes | specification failure |
| NDC | 76282-0405, 76282-0405-01, 76282-0405-05, 76282-0405-30, 76282-0405-90, 76282-0406, 76282-0406-01, 76282-0406-05, 76282-0406-30, 76282-0406-90 |
| Lot numbers | NB900413 |
| Expiration dates | 2020-12 |
Product
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
Reason for recall
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
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-1272-2020. 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.