Class III · Lower riskRecall completed
Gabapentin Oral Solution
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberBatch# 359774; Exp. 09/02/19
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byHi-Tech Pharmacal Co., Inc. Amityville, NY 11701
| Distributed by / for | Akorn Inc |
| NDC | 50383-311-47 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Akorn Inc |
| Distribution | Nationwide |
| Quantity | 4,885 bottles |
| Recall initiated | 2017-12-15 |
| Report date | 2018-01-17 |
| Recall completed | 2019-04-10 |
| Recall number | D-0211-2018 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Lake Forest IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.