Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Recalled by Teligent Pharma, Inc. Due to CGMP Deviations: Lots recalled because they were manufactured...

Date: October 12, 2021
Company: Teligent Pharma, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teligent Pharma, Inc. directly.

Affected Products

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

Quantity: 14,664 glass bottles

Why Was This Recalled?

CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teligent Pharma, Inc.

Teligent Pharma, Inc. has 63 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report