Gabapentin Oral Solution — Class II drug recall D-0301-2021
Terminated recall by Akorn, Inc., reported 2021-03-24, distributed nationwide. Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 mont
| Recall number | D-0301-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2021-03-08 |
| Classified | 2021-03-16 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2022-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 8,183 units |
| Reason classes | specification failure |
| NDC | 50383-0311-07 |
| Lot numbers | 369409, 372393, 373112 |
| Expiration dates | 2021-05, 2022-01, 2022-04 |
Product
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
Reason for recall
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month 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-0301-2021. 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.