Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gabapentin Oral Solution Recalled by Akorn, Inc. Due to Failed Impurities/Degradation Specifications; out of specification for unknown...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Akorn, Inc. directly.
Affected Products
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
Quantity: 8,183 unit dose cups
Why Was This Recalled?
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn, Inc.
Akorn, Inc. has 176 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report