Medications & Supplements/Topical Products

Lidocaine and Prilocaine Cream Recalled for Manufacturing Deviations

Agency Publication Date: April 27, 2022

Summary

Teva Pharmaceuticals USA Inc. has recalled approximately 353,964 units of Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, because of manufacturing deviations that do not meet quality standards. This prescription-only topical medication was distributed in 5 gram and 30 gram tubes. No injuries or adverse incidents have been reported to date in connection with this recall.

Risk

Manufacturing issues can result in a medication that does not meet safety or quality specifications, potentially leading to skin irritation or the product not working effectively during medical procedures.

What You Should Do

This recall affects Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in 5 g tubes (NDC 0591-2070-72) and 30 g tubes (NDC 0591-2070-30).
To identify affected product, check the lot number and expiration date on your tube or carton. Affected codes include lots 16291, 16469, 16255, 16256, 16412, 16257, 16258, 16505, 6506, 16627, 16786, 16787, and 16820. 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 Teva Pharmaceuticals USA Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

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 2.5% and Prilocaine 2.5% Cream, USP (5 g tube)

Variants: 5 g tubes, Rx Only

Lot Numbers:

16291 (Exp. Date 01/2024)

16469 (Exp. Date 02/2024)

NDC:

0591-2070-72

Manufactured by Teligent Pharma, Inc. and distributed by Actavis Pharma, Inc.

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

Variants: 30 g tubes, Rx Only

Lot Numbers:

16255 (Exp. Date 11/2022)

16256 (Exp. Date 02/2024)

16412 (Exp. Date 02/2024)

16257 (Exp. Date 12/2022)

16258 (Exp. Date 12/2022)

16505 (Exp. Date 03/2024)

6506 (Exp. Date 03/2024)

16627 (Exp. Date 04/2024)

16786 (Exp. Date 04/2024)

16787 (Exp. Date 04/2024)

16820 (Exp. Date 04/2024)

NDC:

0591-2070-30

Manufactured by Teligent Pharma, Inc. and distributed by Actavis Pharma, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89944

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA Inc

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 353964 units

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 affects Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in 5 g tubes (NDC 0591-2070-72) and 30 g tubes (NDC 0591-2070-30).

To identify affected product, check the lot number and expiration date on your tube or carton. Affected codes include lots 16291, 16469, 16255, 16256, 16412, 16257, 16258, 16505, 6506, 16627, 16786, 16787, and 16820. 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 Teva Pharmaceuticals USA Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

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 2.5% and Prilocaine 2.5% Cream, USP (5 g tube)

Variants: 5 g tubes, Rx Only

Lot Numbers:

16291 (Exp. Date 01/2024)

16469 (Exp. Date 02/2024)

NDC:

0591-2070-72

Manufactured by Teligent Pharma, Inc. and distributed by Actavis Pharma, Inc.

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

Variants: 30 g tubes, Rx Only

Lot Numbers:

16255 (Exp. Date 11/2022)

16256 (Exp. Date 02/2024)

16412 (Exp. Date 02/2024)

16257 (Exp. Date 12/2022)

16258 (Exp. Date 12/2022)

16505 (Exp. Date 03/2024)

6506 (Exp. Date 03/2024)

16627 (Exp. Date 04/2024)

16786 (Exp. Date 04/2024)

16787 (Exp. Date 04/2024)

16820 (Exp. Date 04/2024)

NDC:

0591-2070-30

Manufactured by Teligent Pharma, Inc. and distributed by Actavis Pharma, Inc.