LITE Regener-Eyes — Class II drug recall D-0152-2025
Terminated recall by Regenerative Processing Plant, LLC, reported 2024-12-25, distributed nationwide. Lack of Sterility Assurance
| Recall number | D-0152-2025 |
|---|---|
| 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 | 170,812 bottles |
| Reason classes | sterility |
| NDC | 82305-0006-01 |
| Lot numbers | P010223A, P010323LV1, P010523A, P010523B, P010923A, P011023LV2, P011223A, P011223B, P011623A, P011723LV3, P011923A, P011923B, P012323A, P012323B, P012523A, P013123A, P020223A, P020623A, P020823A, P020923A, P021323A, P021523A, P021523B, P021623A, P022023A, P022123A, P022323A, P022723A, P030123A, P030223A, P030623A, P030723A, P030823A, P030923A, P031423A, P032023A, P032123A, P032223A, P032723A, P040423A and 50 more |
| Expiration dates | 2024-12-13, 2024-12-14, 2024-12-19, 2024-12-20, 2024-12-21, 2024-12-26, 2024-12-27, 2024-12-28, 2025-01-02, 2025-01-03, 2025-01-05, 2025-01-09, 2025-01-10, 2025-01-12, 2025-01-16, 2025-01-17, 2025-01-19, 2025-01-23, 2025-01-25, 2025-01-31, 2025-02-02, 2025-02-06, 2025-02-08, 2025-02-09, 2025-02-13 and 54 more |
Product
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01
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-0152-2025. 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.