Unrated Drug recall · FDA · Published October 12, 2021

Teligent Pharma recalls Lidocaine 4% topical solution for superpotent drug risk

Teligent Pharma recalls 50mL glass Lidocaine 4% topical solution (Rx only) due to superpotent drug hazard. Product sold with specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #D-0280-2022Drug Teligent Pharma ›

Recall notice

Superpotent Drug

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Teligent Pharma is recalling 50mL glass bottles of Lidocaine Hydrochloride Topical Solution 4% (Rx only) because it's a superpotent drug. This recall is for safety reasons related to the medication's strength. Read more at govinfonow.com/recall/35664-teligent-pharma-recalls-lidocaine-4-topical-solution-for-superpotent-drug.

Source Summary by GovInfoNow · govinfonow.com/recall/35664-teligent-pharma-recalls-lidocaine-4-topical-solution-for-superpotent-drug · Updated August 18, 2026 · FDA enforcement record: FDA #D-0280-2022

Cite this page

“Teligent Pharma recalls Lidocaine 4% topical solution for superpotent drug risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35664-teligent-pharma-recalls-lidocaine-4-topical-solution-for-superpotent-drug. Based on FDA recall #D-0280-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0280-2022%22&limit=1).

The FDA announced on 2021-10-12 that Teligent Pharma, Inc. voluntarily recalled Lidocaine Hydrochloride Topical Solution USP 4% due to superpotent drug risks. The recall affects 52,104 glass 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 glass bottles
NDC: 52565-009-50
Lot #: 13262, Exp. 03/2022
Lot #: 14217, Exp. 08/2022

The hazard

The product is classified as a superpotent drug. The FDA categorized this recall as Class I.

Context

GovInfoNow's records show Teligent Pharma, Inc. has had 18 other recalls on record since 2019-05-20. Other recent recalls of similar products include Spectra Medical Recalls Lidocaine Ampules Due to Sterility Risk (2026-05-12), Preferred Pharma Recalls Lidocaine Ointment Due to Content Issues (2026-09-28), and Asclemed Lidocaine HCl Injection Recall: Risk of Contaminated Medication (2026-06-08).

How to tell if you have this one

Check for 50mL glass bottles labeled 'Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL)'. The product was sold with specific lot numbers (13262 or 14217) and expiration dates (03/2022 or 08/2022).

Brand
Teligent Pharma
Category
Drug

FDA recall event · 3 products

All 3 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
Terminated
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity	Class	NDC
D-0279-2022	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.; Lot #: 16306, Exp. Date 01/2024.	7,008 glass bottles	Class II	63739-997-64
D-0280-2022	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; Lot #: 13262, Exp. 03/2022; 14217, Exp. 08/2022	52,104 glass bottles	Class I	—
D-0281-2022	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; Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022	14,664 glass bottles	Class II	—

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product's lot number and expiration date to confirm if it's part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

Oct 12, 2021Firm started the recall
Dec 13, 2021FDA classified it Class I
Dec 22, 2021Published in FDA’s Enforcement Report
Jun 18, 2024FDA terminated the recall

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/35664-teligent-pharma-recalls-lidocaine-4-topical-solution-for-superpotent-drug">Teligent Pharma recalls Lidocaine 4% topical solution for 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-0280-2022 (October 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0280-2022 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.