FDA Drug recall D-0295-2022
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma…
- FDA Drug
- Class I
- ongoing
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class I recall of Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma… by Teligent Pharma, citing superpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0295-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-11-30 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teligent Pharma |
| Distribution | US |
Product
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
Reason
Superpotent Drug
Identifiers
| ndc | 63739-997-64 |
|---|---|
| code_info | Lot #: 16345, Exp. Date 01/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Teligent Pharma
- Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by:…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0295-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.