Medications & Supplements/Prescription Drugs

Akorn, Inc.: Gabapentin Oral Solution Recalled for Failed Impurity Specifications

Agency Publication Date: March 16, 2021

Summary

Akorn, Inc. is recalling 8,183 units of Gabapentin Oral Solution (250 mg/5 mL) because the product failed stability testing due to an unknown impurity. This prescription medication, often used to treat seizures or nerve pain, was distributed nationwide in individual 5 mL unit dose cups. Consumers should check their medicine supply immediately to see if their specific lot is included in this recall. If you have this medication, do not use it and contact your healthcare provider or pharmacist for a replacement.

Risk

The presence of an unknown impurity or degradation product means the medication does not meet safety and quality specifications, which could potentially lead to reduced effectiveness or unexpected side effects during treatment.

What You Should Do

Identify your medication by checking the NDC numbers and lot information on the unit dose cup or tray packaging. This recall affects Gabapentin Oral Solution, 250 mg/5 mL, with NDC Tray: 50383-311-07 and NDC Unit Dose Cup 50383-311-07.
Check for the following specific lot numbers and expiration dates: Lot 369409 (Exp. 05/2021), Lot 372393 (Exp. 01/2022), and Lot 373112 (Exp. 04/2022).
If your medication matches these lot numbers, contact your healthcare provider or pharmacist immediately to discuss alternative treatment and how to obtain a replacement.
Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund and to ensures it is disposed of properly.
Contact Akorn, Inc. at the distributor address (1925 W Field Ct Ste 300, Lake Forest, Illinois) or your pharmacist for further instructions regarding the return process.
For additional questions or to report a problem, 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

Return for refund and consultation

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 (5 mL unit dose cup)

Model:

NDC Tray: 50383-311-07

NDC Unit Dose Cup 50383-311-07

Lot Numbers:

369409 (Exp. 05/2021)

372393 (Exp. 01/2022)

373112 (Exp. 04/2022)

Date Ranges: Expiration Date 05/2021, Expiration Date 01/2022, Expiration Date 04/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87462

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: hospitals; pharmacies; institutional healthcare facilities

Manufactured In: United States

Units Affected: 8,183 unit dose cups

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

Identify your medication by checking the NDC numbers and lot information on the unit dose cup or tray packaging. This recall affects Gabapentin Oral Solution, 250 mg/5 mL, with NDC Tray: 50383-311-07 and NDC Unit Dose Cup 50383-311-07.

Check for the following specific lot numbers and expiration dates: Lot 369409 (Exp. 05/2021), Lot 372393 (Exp. 01/2022), and Lot 373112 (Exp. 04/2022).

If your medication matches these lot numbers, contact your healthcare provider or pharmacist immediately to discuss alternative treatment and how to obtain a replacement.

Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund and to ensures it is disposed of properly.

Contact Akorn, Inc. at the distributor address (1925 W Field Ct Ste 300, Lake Forest, Illinois) or your pharmacist for further instructions regarding the return process.

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