Medications & Supplements/Prescription Drugs

Akorn Inc: Gabapentin Oral Solution Recalled for Unapproved Ingredient Source

Agency Publication Date: January 8, 2018

Summary

Akorn Inc. is recalling 4,885 bottles of Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL). This prescription medication was manufactured by Hi-Tech Pharmacal Co., Inc. and is being recalled because it was produced using an active ingredient from an unapproved manufacturer. This deviation from manufacturing standards could potentially impact the safety or effectiveness of the drug, though no specific incidents have been reported.

Risk

The use of an active ingredient from an unapproved source means the safety, purity, and potency of the medication cannot be guaranteed according to FDA standards. This manufacturing deviation could result in the drug not performing as intended for patients managing seizures or nerve pain.

What You Should Do

Check your medicine cabinet for Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in 470 mL amber-colored bottles.
Verify if your bottle matches NDC 50383-311-47 and Batch/Lot number 359774 with an expiration date of 09/02/19.
If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or replacement.
Return any unused portions of the medication to the pharmacy where you purchased it for a refund.
For further questions regarding this recall, contact Akorn Inc. or the manufacturer, Hi-Tech Pharmacal Co., Inc.
For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) (470 mL)

Model:

NDC: 50383-311-47

Recall #: D-0211-2018

Lot Numbers:

359774 (Exp. 09/02/19)

Date Ranges: Exp. 09/02/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78730

Status: Resolved

Manufacturer: Akorn Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 4,885 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medicine cabinet for Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in 470 mL amber-colored bottles.

Verify if your bottle matches NDC 50383-311-47 and Batch/Lot number 359774 with an expiration date of 09/02/19.

If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or replacement.

Return any unused portions of the medication to the pharmacy where you purchased it for a refund.

For further questions regarding this recall, contact Akorn Inc. or the manufacturer, Hi-Tech Pharmacal Co., Inc.

For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.