Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Gabapentin Oral Solution Recalled by Akorn Inc Due to CGMP Deviations: Inadvertent release of a drug product...
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 (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
Quantity: 4,885 bottles
Why Was This Recalled?
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn Inc
Akorn Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report