Use caution Drug recall · FDA · Published April 21, 2022

McKesson Recalls Lidocaine Topical Solution Due to CGMP Deviations

McKesson recalls Lidocaine Hydrochloride Topical Solution USP 4% due to CGMP deviations. Check lot numbers and expiration dates for affected batches.

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

🇺🇸 FDA recall #D-0848-2022Drug McKesson ›

Use caution until it’s fixed

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Take action

Contact the company

Recalling firmMcKesson Corporation dba McKesson Drug Company4853 Crumpler Rd · Memphis, TN 38141-8301

✎ GovInfoNow plain-language explainer

McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution USP 4% because of Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, Teligent Pharma, Inc., is discontinuing its stability study program, which affects all products within their expiry dates. This recall covers approximately 81,757 bottles distributed nationwide. Read more at govinfonow.com/recall/34819-mckesson-recalls-lidocaine-topical-solution-due-to-cgmp-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/34819-mckesson-recalls-lidocaine-topical-solution-due-to-cgmp-deviations · Updated October 10, 2026 · FDA enforcement record: FDA #D-0848-2022

Cite this page

“McKesson Recalls Lidocaine Topical Solution Due to CGMP Deviations.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34819-mckesson-recalls-lidocaine-topical-solution-due-to-cgmp-deviations. Based on FDA recall #D-0848-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0848-2022%22&limit=1).

The FDA announced on April 21, 2022, that McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to CGMP deviations. The agency stated the recall addresses discontinuation of stability studies by manufacturer Teligent Pharma.

How to tell if you have it

Brand: McKesson
Product: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL)
Package: 50 mL bottle, Rx only
NDC: 63739-977-64
Lots: 15597 (Exp. 05/31/2023), 16305 (Exp. 12/23/2023), 16334 (Exp. 01/31/2024), 16340 (Exp. 01/31/2024), 16346 (Exp. 01/31/2024), 16356 (Exp. 01/31/2024), 16357 (Exp. 01/31/2024)
Manufacturer: Teligent Pharma, Inc.
Distributor: McKesson Corporation dba Sky Packaging
Units affected: 81,757 bottles

The hazard

The FDA said the recall covers all products within expiry because manufacturer Teligent Pharma, Inc. is discontinuing its stability study program. This constitutes CGMP deviations.

Context

GovInfoNow's records show McKesson Corporation dba McKesson Drug Company has 1 other recall on record since 2021-05-26. On 2021-05-26, McKesson Drug Company recalled Levetiracetam Tablets due to a barcode error that could result in units being read as Naproxen Tablets 500 mg. Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall (2026-04-01), Wells Pharma Ketamine Injectable Solution Recall (2026-04-01), and Wells Pharma fentanyl injectable solution recall due to manufacturing deviations (2026-04-01).

How to tell if you have this one

Look for a 50 mL bottle of Lidocaine Hydrochloride Topical Solution USP 4% (Rx only). Check the NDC 63739-977-64 and verify if your lot number is one of: 15597, 16305, 16334, 16340, 16346, 16356, or 16357. The expiration dates for these lots range from May 2023 to January 2024.

Brand
McKesson
Category
Drug

FDA recall event · 5 products

All 5 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.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.

Recall number	Product, codes & lots	Quantity
D-0847-2022	Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67; Lots: 15720, Exp.: 06/30/2022; 16449 Exp.: 02/28/2023; 16450, Exp.: 02/26/2023	13, 200 tubes
D-0848-2022	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64; Lots: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 01/31/2024; 16356, Exp.: 01/31/2024; 16357, Exp.: 01/31/2024	81,757 bottles
D-0849-2022	Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66; Lot: 16876, Exp.: 05/31/2023	1176 tubes
D-0850-2022	Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, 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 63739-996-65; Lot: 15644, Exp.: 05/31/2022	55,440 tubes
D-0851-2022	Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, 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 63739-053-68; Lot: 15723, Exp.: 06/30/2022	5,640 tubes

Based on the official FDA remedy

What to do — step by step

Check Your Lot Number
Verify if your bottle's lot number matches one of the recalled lots: 15597, 16305, 16334, 16340, 16346, 16356, or 16357.
Contact Your Pharmacist
If you have an affected lot, contact your pharmacy or healthcare provider to discuss replacement options or disposal instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the United States including Guam and the Northern Mariana Islands.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 20 days after the firm started it.

Apr 21, 2022Firm started the recall
May 5, 2022FDA classified it Class II
May 11, 2022Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product sold?

The product was distributed nationwide in the United States, including Guam and the Northern Mariana Islands.

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Link to this recall

<a href="https://govinfonow.com/recall/34819-mckesson-recalls-lidocaine-topical-solution-due-to-cgmp-deviations">McKesson Recalls Lidocaine Topical Solution Due to CGMP Deviations (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-0848-2022 (April 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0848-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.