FDA Drug recall D-1232-2020
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc by Aurobindo Pharma Usa, citing CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1232-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-18 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Identifiers
| ndc | 65862-198-01 |
|---|---|
| ndc | 65862-198-05 |
| ndc | 65862-198-99 |
| ndc | 65862-198-10 |
| ndc | 65862-198-90 |
| ndc | 65862-198-18 |
| ndc | 65862-198-27 |
| ndc | 65862-199-01 |
| ndc | 65862-199-05 |
| ndc | 65862-199-99 |
| ndc | 65862-199-10 |
| ndc | 65862-199-30 |
| ndc | 65862-199-60 |
| ndc | 65862-199-90 |
| ndc | 65862-199-18 |
| ndc | 65862-199-27 |
| ndc | 65862-200-01 |
| ndc | 65862-200-05 |
| ndc | 65862-200-10 |
| ndc | 65862-200-90 |
| ndc | 65862-200-27 |
| code_info | Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
All Aurobindo Pharma Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1232-2020%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.