Medications & Supplements/Topical Products

Teligent Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

Agency Publication Date: December 13, 2021

Summary

Teligent Pharma, Inc. is recalling 73,776 bottles of Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) because the product may be superpotent. Some bottles were manufactured with cracked seals or caps, which can cause the medication to become too concentrated. No injuries or incidents have been reported to date regarding this recall. This prescription medication is applied to the skin and was sold nationwide in 50 mL glass bottles.

Risk

Using a superpotent lidocaine solution can cause the body to absorb too much of the drug, leading to lidocaine toxicity. Potential symptoms of toxicity include dizziness, confusion, seizures, or irregular heart rhythms.

What You Should Do

The recalled products are 50 mL glass bottles of Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) sold under the Teligent and Sky Packaging brands.
Check your medicine bottle and packaging for NDC codes 63739-997-64 or 52565-009-50. Affected lot numbers include 16306, 13262, 14217, 13058, and 13768. 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 Teligent Pharma, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 Topical Solution USP 4% (40 mg/mL) (50 mL)by Sky Packaging

Variants: 4%, 40 mg/mL, Topical Solution

UPC Codes:

363739997646

Lot Numbers:

16306 (Exp. Date 01/2024)

NDC:

63739-997-64

Distributed by McKesson Corporation dba Sky Packaging.

Product: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) (50 mL)by Teligent

Variants: 4%, 40 mg/mL, Topical Solution

UPC Codes:

352565009500

Lot Numbers:

13262 (Exp. 03/2022)

14217 (Exp. 08/2022)

13058 (Exp. date 02/2022)

13768 (Exp. date 05/2022)

NDC:

52565-009-50

Product Images

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL, NDC 52565-009-50”

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL, NDC 63739-997-64

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88850

Status: Resolved

Manufacturer: Teligent Pharma, Inc.

Sold By: McKesson Corporation dba Sky Packaging; Pharmacies

Manufactured In: United States

Units Affected: 3 products (7,008 glass bottles; 52,104 glass bottles; 14,664 glass bottles)

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 · FDA Press Release · 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

The recalled products are 50 mL glass bottles of Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) sold under the Teligent and Sky Packaging brands.

Check your medicine bottle and packaging for NDC codes 63739-997-64 or 52565-009-50. Affected lot numbers include 16306, 13262, 14217, 13058, and 13768. 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 Teligent Pharma, Inc. for further instructions.

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

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 Topical Solution USP 4% (40 mg/mL) (50 mL)by Sky Packaging

Variants: 4%, 40 mg/mL, Topical Solution

UPC Codes:

363739997646

Lot Numbers:

16306 (Exp. Date 01/2024)

NDC:

63739-997-64

Distributed by McKesson Corporation dba Sky Packaging.

Product: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) (50 mL)by Teligent

Variants: 4%, 40 mg/mL, Topical Solution

UPC Codes:

352565009500

Lot Numbers:

13262 (Exp. 03/2022)

14217 (Exp. 08/2022)

13058 (Exp. date 02/2022)

13768 (Exp. date 05/2022)

NDC:

52565-009-50

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88850

Status: Resolved

Manufacturer: Teligent Pharma, Inc.

Sold By: McKesson Corporation dba Sky Packaging; Pharmacies

Manufactured In: United States

Units Affected: 3 products (7,008 glass bottles; 52,104 glass bottles; 14,664 glass bottles)

Distributed To: Nationwide