CLASS II ONGOING Drug recall · Reported 11 May 2022 · FDA Enforcement Report
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) recalled
McKesson is recalling Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), distributed nationwide in the US. The recall was initiated on 21 Apr 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0848-2022
- FDA event ID
- 89986
- Recalling firm
- McKesson, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2022
- FDA classified
- 5 May 2022
- Reported
- 11 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 21 Apr 2022 | Recall initiated by company | |
| 5 May 2022 | Classified by FDA | +14 days |
| 11 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the United States including Guam and the Northern Mariana Islands.
Questions about this recall
Why was it recalled?
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Which lots are affected?
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
Where was it sold?
Nationwide in the United States including Guam and the Northern Mariana Islands.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 89986| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Erythromycin Topical Gel recalled by McKesson | McKesson | Potency & Assay | Nationwide | |
| CLASS II | Halobetasol Propionate Ointment recalled by McKesson | McKesson | Potency & Assay | Nationwide | |
| CLASS II | Lidocaine Prilocaine Cream USP, 2.5%/2.5% recalled by McKesson | McKesson | Potency & Assay | Nationwide | |
| CLASS II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) recalled | McKesson | Potency & Assay | Nationwide |
More recalls from McKesson
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gemcitabine Injection per (38 mg/mL) Single-Dose Vial recalledGemcitabine | McKesson | Temperature Abuse | Nationwide |
| Drug | CLASS I | Udenyca, pegfilgrastim-cbqv injection recalled by McKessonUdenyca | McKesson | Temperature Abuse | Nationwide |
| Drug | CLASS II | Inflectra (infliximab-dyyb), For injection, 100mg per vial recalledInflectra | McKesson | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cabtreo (clindamycin phosphate, adapalene recalled by MckessonCabtreo | Mckesson | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) recalled | McKesson | Potency & Assay | Nationwide |
Other Lidocaine recalls
All 120| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Ointment USP, 5%, Speermint Flavor recalledLidocaine | SUN Pharma /Taro | Potency & Assay | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |