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Class II · ModerateRecall completed

Gabapentin Oral Solution

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
Where it was soldNationwide USA
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

Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forAkorn, Inc.
Show the full FDA record
Full product labelGabapentin 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
Recalling firmAkorn, Inc.
DistributionNationwide USA
Quantity8,183 unit dose cups
Recall initiated2021-03-08
Report date2021-03-24
Recall completed2022-08-09
Recall numberD-0301-2021
ClassificationClass II
FDA statusTerminated
Origin on fileLake Forest IL United States

Related

Gabapentin recallsRecent drug recallsCheck another medication

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.