Gabapentin Capsules — Class II drug recall D-1232-2020
Terminated recall by Aurobindo Pharma USA Inc., reported 2020-04-22, distributed nationwide. CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
| Recall number | D-1232-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2020-03-18 |
| Classified | 2020-04-13 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2024-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 26,625 units |
| Reason classes | cgmp, packaging |
| NDC | 65862-0198, 65862-0198-01, 65862-0198-05, 65862-0198-10, 65862-0198-18, 65862-0198-27, 65862-0198-90, 65862-0198-99, 65862-0199, 65862-0199-01, 65862-0199-05, 65862-0199-10, 65862-0199-18, 65862-0199-27, 65862-0199-30, 65862-0199-60, 65862-0199-90, 65862-0199-99, 65862-0200, 65862-0200-01, 65862-0200-05, 65862-0200-10, 65862-0200-27, 65862-0200-90 |
| Lot numbers | 198180048A, 198180061A, 19819017A1 |
| Expiration dates | 2020-06, 2021-02, 2021-04 |
Product
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
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-1232-2020. 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.