FDA Drug recall D-0211-2018
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class III recall of Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only by Akorn, citing CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0211-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-12-15 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Identifiers
| code_info | Batch# 359774; Exp. 09/02/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0211-2018%22
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