Gabapentin Oral Solution — Class III drug recall D-0211-2018
Terminated recall by Akorn Inc, reported 2018-01-17, distributed nationwide. CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
| Recall number | D-0211-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2017-12-15 |
| Classified | 2018-01-08 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2019-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 4,885 bottles |
| Reason classes | cgmp, unapproved product |
| NDC | 50383-0311-47 |
| Lot numbers | 359774 |
| Expiration dates | 2019-09-02 |
Product
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
Reason for recall
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
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-0211-2018. 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.