Lidocaine Hydrochloride Topical Solution USP 4% — Class II drug recall D-0279-2022
Terminated recall by Teligent Pharma, Inc., reported 2021-12-22, distributed nationwide. CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components a
| Recall number | D-0279-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2021-10-12 |
| Classified | 2021-12-13 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 7,008 glass |
| Reason classes | potency, cgmp, packaging |
| NDC | 63739-0997, 63739-0997-64 |
| Lot numbers | 16306 |
| Expiration dates | 2024-01 |
Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
Reason for recall
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0279-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.