Lidocaine Ointment USP — Class II drug recall D-0694-2022
Terminated recall by Teligent Pharma, Inc., reported 2022-03-30, distributed nationwide. cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability
| Recall number | D-0694-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2022-03-15 |
| Classified | 2022-03-21 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 100,256 tubes |
| Reason classes | cgmp, specification failure |
| NDC | 52565-0008-14 |
| Lot numbers | 16389, 16452 |
| Expiration dates | 2024-02-29 |
Product
Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.
Reason for recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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-0694-2022. 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.