PROFESSIONAL Regener-Eyes — Class II drug recall D-0153-2025
Terminated recall by Regenerative Processing Plant, LLC, reported 2024-12-25, distributed nationwide. Lack of Sterility Assurance
| Recall number | D-0153-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Regenerative Processing Plant, LLC, Palm Harbor, FL, United States |
| Recall initiated | 2024-12-10 |
| Classified | 2024-12-17 |
| Reported by FDA | 2024-12-25 |
| Terminated | 2025-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 59,275 |
| Reason classes | sterility |
| NDC | 82305-0003-01 |
| Lot numbers | 2/1, 2025, P010223A, P010423PV1, P010523A, P010523B, P010923A, P011123PV2, P011223A, P011223B, P011623A, P011823PV3, P011923A, P011923B, P012323A, P012323B, P012623A, P013023A, P020123A, P020723A, P021423, P021623A, P022023A, P022223A, P022823A, P030123A, P050423A, P051823A, P052523A, P120522A, P120522B, P1208228, P120822A, P1212228, P121222A, P121922A, P121922B, P122222A, P122622A, P122622B |
| Expiration dates | 2024-12-05, 2024-12-08, 2024-12-12, 2024-12-19, 2024-12-22, 2024-12-26, 2025-01-02, 2025-01-04, 2025-01-05, 2025-01-09, 2025-01-11, 2025-01-12, 2025-01-16, 2025-01-18, 2025-01-19, 2025-01-23, 2025-01-26, 2025-01-30, 2025-02-07, 2025-02-14, 2025-02-16, 2025-02-20, 2025-02-22, 2025-02-28, 2025-03-01 and 4 more |
Product
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
Reason for recall
Lack of Sterility Assurance
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-0153-2025. 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.