CLASS I Drug recall · Reported 22 Dec 2021 · 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 12 Oct 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-0280-2022
- FDA event ID
- 88850
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 12 Oct 2021
- FDA classified
- 13 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 12 Oct 2021 | Recall initiated by company | |
| 13 Dec 2021 | Classified by FDA | +62 days |
| 22 Dec 2021 | Published in enforcement report | +9 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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) recalled?
Yes. Teligent Pharma recalled Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) on 12 Oct 2021. The recall is Class I and its status is Terminated. Recall number D-0280-2022.
Why was it recalled?
Superpotent Drug
Which lots are affected?
Lot #: 13262, Exp. 03/2022; 14217, Exp. 08/2022
Where was it sold?
Nationwide within the United States
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 hydrochloride topical recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) recalled | McKesson | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) recalled | Teligent Pharma | Foreign Material | Nationwide |
| Drug | CLASS I | Lidocaine Hydrochloride Topical Solution recalled by Teligent Pharma | Teligent Pharma | Foreign Material | Nationwide |