Medications & Supplements/Prescription Drugs

Akorn Lidocaine and Sodium Chloride Ointments Recalled for Quality Issues

Agency Publication Date: September 6, 2022

Summary

Akorn, Inc. is recalling approximately 131,325 tubes of Lidocaine Hydrochloride Jelly (2%) and Sodium Chloride Ophthalmic Ointment (5%) due to manufacturing quality issues. The recall was initiated after turbidity (cloudiness) was discovered in a related ointment during sterility testing, leading to concerns that these products may not meet quality standards. No injuries or illnesses have been reported to date.

Risk

Manufacturing deviations and the presence of turbidity in sterile products can indicate a risk of microbial contamination. Using contaminated sterile products on broken skin or in the eyes could lead to serious infections.

What You Should Do

This recall involves Akorn Lidocaine Hydrochloride Jelly USP, 2% (NDC 17478-711-31) and Sodium Chloride Ophthalmic Ointment USP, 5% (NDC 17478-622-35).
Check the product packaging for the NDC numbers and lot numbers such as 9J36A, 9K62A, or 9J58A. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lidocaine Hydrochloride Jelly USP, 2%, Sterile (30mL)

Variants: 2%, 30mL tube, Rx only

Lot Numbers:

9J36A (Exp 8/31/2022)

9J36B (Exp 8/31/2022)

9J39A (Exp 8/31/2022)

9J39B (Exp 8/31/2022)

9J39C (Exp 8/31/2022)

9J39D (Exp 8/31/2022)

9J39E (Exp 8/31/2022)

9J42B (Exp 8/31/2022)

9J42C (Exp 8/31/2022)

9K62A (Exp 9/30/2022)

9K62B (Exp 9/30/2022)

9K62C (Exp 9/30/2022)

9M04A (Exp 11/30/2022)

9M04B (Exp 11/30/2022)

NDC:

17478-711-31

Quantity: 82,689 tubes.

Product: Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile (3.5 g)

Variants: 5%, 3.5 g (1/8 oz) tube

Lot Numbers:

9J58A (Exp 8/31/2022)

9J58B (Exp 8/31/2022)

NDC:

17478-622-35

Quantity: 48,636 tubes.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90813

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Pharmacies; Hospitals

Manufactured In: United States

Units Affected: 2 products (82,689 tubes; 48,636 tubes)

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

This recall involves Akorn Lidocaine Hydrochloride Jelly USP, 2% (NDC 17478-711-31) and Sodium Chloride Ophthalmic Ointment USP, 5% (NDC 17478-622-35).

Check the product packaging for the NDC numbers and lot numbers such as 9J36A, 9K62A, or 9J58A. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lidocaine Hydrochloride Jelly USP, 2%, Sterile (30mL)

Variants: 2%, 30mL tube, Rx only

Lot Numbers:

9J36A (Exp 8/31/2022)

9J36B (Exp 8/31/2022)

9J39A (Exp 8/31/2022)

9J39B (Exp 8/31/2022)

9J39C (Exp 8/31/2022)

9J39D (Exp 8/31/2022)

9J39E (Exp 8/31/2022)

9J42B (Exp 8/31/2022)

9J42C (Exp 8/31/2022)

9K62A (Exp 9/30/2022)

9K62B (Exp 9/30/2022)

9K62C (Exp 9/30/2022)

9M04A (Exp 11/30/2022)

9M04B (Exp 11/30/2022)

NDC:

17478-711-31

Quantity: 82,689 tubes.

Product: Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile (3.5 g)

Variants: 5%, 3.5 g (1/8 oz) tube

Lot Numbers:

9J58A (Exp 8/31/2022)

9J58B (Exp 8/31/2022)

NDC:

17478-622-35

Quantity: 48,636 tubes.