CLASS I ONGOING Drug recall · Reported 5 Jan 2022 · FDA Enforcement Report
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL) recalled
Teligent Pharma is recalling Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), distributed nationwide in the US. The recall was initiated on 30 Nov 2021 and the FDA has classified it as Class I.
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-0295-2022
- FDA event ID
- 89135
- Recalling firm
- Teligent Pharma, Buena, NJ
- Manufacturer
- McKesson Corporation dba SKY Packaging
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 Nov 2021
- FDA classified
- 28 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 30 Nov 2021 | Recall initiated by company | |
| 28 Dec 2021 | Classified by FDA | +28 days |
| 5 Jan 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug
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), 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
Where it was distributed
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Superpotent Drug
Which lots are affected?
Lot #: 16345, Exp. Date 01/2024
Where was it sold?
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
1 other product · FDA event 89135This product is part of a recall event; the main page for the event is Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL) recalledLidocaine Hydrochloride | Teligent Pharma | Potency & Assay | Nationwide |
More recalls from Teligent Pharma
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Econazole Nitrate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Topical Solution recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Gel recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diflorasone Diacetate Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
Other Lidocaine recalls
All 119| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Ointment USP, 5% (Generic for Xylocaine) recalled | Preferred Pharmaceuticals | Packaging Defects | Nationwide |
| 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 |