Lidocaine HCl 4% ophthalmic solution — Class II drug recall D-0062-2024
Terminated recall by Pine Pharmaceuticals, LLC, reported 2023-10-25, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0062-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pine Pharmaceuticals, LLC, Tonawanda, NY, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2023-10-19 |
| Reported by FDA | 2023-10-25 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 1,598 droppers |
| Reason classes | sterility |
| Lot numbers | 67443, 68775 |
| Expiration dates | 2023-10-08, 2023-12-09 |
Product
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason for recall
Lack of Assurance of Sterility
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-0062-2024. 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.