Lidocaine Ointment USP — Class III drug recall D-0331-2021
Terminated recall by Teligent Pharma, Inc., reported 2021-04-21, distributed nationwide. Failed Stability Specifications: product did not meet viscosity results.
| Recall number | D-0331-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2021-03-29 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2024-07-03 |
| Distributed | Nationwide (US) |
| Quantity | 62,040 tubes |
| Reason classes | specification failure |
| NDC | 52565-0008-14 |
| Lot numbers | 13269 |
| Expiration dates | 2021-03-20 |
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
Failed Stability Specifications: product did not meet viscosity results.
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-0331-2021. 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.