Unrated Drug recall · FDA · Published November 30, 2021

Teligent Pharma recalls 4% Lidocaine Topical Solution: Superpotent Drug Risk

Teligent Pharma recalls 4% Lidocaine Hydrochloride topical solution (50mL bottles) due to superpotent drug risk. This prescription medication may cause serious injury if misused.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0296-2022Drug Teligent Pharma ›

Recall notice

Superpotent Drug: Minimally superpotent

Take action

Contact the company

Recalling firmTeligent Pharma, Inc.105 Lincoln Avenue · Buena, NJ 08310

✎ GovInfoNow plain-language explainer

Teligent Pharma is recalling 4% lidocaine topical solution (50mL bottles) because it's classified as a superpotent drug. This means it could cause serious injury if used incorrectly or inappropriately. Read more at govinfonow.com/recall/35502-teligent-pharma-recalls-4-lidocaine-topical-solution-superpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35502-teligent-pharma-recalls-4-lidocaine-topical-solution-superpotent-drug-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0296-2022

Cite this page

“Teligent Pharma recalls 4% Lidocaine Topical Solution: Superpotent Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35502-teligent-pharma-recalls-4-lidocaine-topical-solution-superpotent-drug-risk. Based on FDA recall #D-0296-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0296-2022%22&limit=1).

The FDA announced on 2021-11-30 that Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride, Topical Solution USP, 4% due to a superpotent drug hazard. The recall affects 7,176 bottles distributed nationwide.

How to tell if you have it

Brand: Teligent Pharma
Product: Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL)
Packaging: 50 mL screw cap bottles
NDC: 63739-997-64
Lot #: 15594
Exp Date: 05/2023

The hazard

The product is classified as a superpotent drug, specifically described as minimally superpotent. The record provides no information regarding incidents or injuries.

Context

GovInfoNow's records show Teligent Pharma, Inc. has had 18 other recalls since 2019-05-20. Recent brand recalls include a Betamethasone Lotion recall on 2022-03-15 for cGMP deviations, an Erythromycin Gel recall on 2022-02-07 for impurities risk, and a Diclofenac Topical Solution recall on 2021-10-19 for defective container risk. Other recent recalls of similar products include Asclemed Lidocaine HCl Injection Recall (2026-06-08), Keystone DHP Topical Anesthetic Gel Recall (2026-05-21), and Spectra Medical Recalls Lidocaine Ampules Due to Sterility Risk (2026-05-12).

How to tell if you have this one

Check for 50mL screw cap bottles labeled 'Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL)' with the NDC code 63739-997-64. This product was distributed by McKesson Corporation and manufactured in Buena, NJ.

Brand
Teligent Pharma
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Status
Ongoing
Distribution
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
NDC
63739-997-64

Recall number	Product, codes & lots	Quantity	Class
D-0295-2022	Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64; Lot #: 16345, Exp. Date 01/2024	6,816 bottles	Class I
D-0296-2022	Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64; Lot #: 15594, Exp Date 05/2023	7,176 bottles	Class II

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product label indicating 50mL bottles of 4% lidocaine hydrochloride topical solution with NDC 63739-997-64.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed to a wholesaler in CO who further distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 36 days after the firm started it.

Nov 30, 2021Firm started the recall
Dec 28, 2021FDA classified it Class II
Jan 5, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35502-teligent-pharma-recalls-4-lidocaine-topical-solution-superpotent-drug-risk">Teligent Pharma recalls 4% Lidocaine Topical Solution: Superpotent Drug Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0296-2022 (November 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0296-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.