Medications & Supplements/Prescription Drugs

Akorn, Inc.: Lidocaine and Prilocaine Cream Recalled for Unknown Impurity

Agency Publication Date: August 6, 2018

Summary

Akorn, Inc. is recalling 22,605 tubes of Lidocaine 2.5% and Prilocaine Cream, 2.5% (30g) due to the discovery of an unknown impurity during stability testing. The affected product is a prescription-only topical anesthetic used to numb the skin. Consumers who have this specific medication should contact their doctor or pharmacist immediately and return the unused portion to their pharmacy for a refund.

Risk

The presence of an unknown impurity or degradation product means the medication failed to meet safety and quality standards, which could potentially cause skin irritation or reduce the effectiveness of the treatment.

What You Should Do

Check your medicine cabinet for Lidocaine 2.5% and Prilocaine Cream, 2.5% in 30g tubes with NDC 50383-667-30.
Verify if your tube belongs to Lot 356309 with an expiration date of 3/2019.
Contact your healthcare provider or pharmacist for guidance if you have used this product and are experiencing any unusual symptoms.
Return any unused product from this specific lot to your pharmacy to receive a refund.
Contact Akorn, Inc. or the distributor at 1925 W Field Ct Ste 300, Lake Forest, Illinois for further instructions regarding this recall.
For additional questions, 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

Contact healthcare provider and return for refund

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

Affected Products

Product: Lidocaine 2.5% and Prilocaine Cream, 2.5% (30g tube)

Model:

NDC 50383-667-30

Recall #: D-1046-2018

Lot Numbers:

356309 (Exp. 3/2019)

Date Ranges: Exp. 3/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80629

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 22,605 tubes

Distributed To: Nationwide

Agency Last Updated: August 7, 2018

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

Check your medicine cabinet for Lidocaine 2.5% and Prilocaine Cream, 2.5% in 30g tubes with NDC 50383-667-30.

Verify if your tube belongs to Lot 356309 with an expiration date of 3/2019.

Contact your healthcare provider or pharmacist for guidance if you have used this product and are experiencing any unusual symptoms.

Return any unused product from this specific lot to your pharmacy to receive a refund.

Contact Akorn, Inc. or the distributor at 1925 W Field Ct Ste 300, Lake Forest, Illinois for further instructions regarding this recall.

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