Class IITerminated

LITE Regener-Eyes recall

FDA recall D-0152-2025 · initiated Dec 10, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Sterility Assurance

Details

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
Recalling company: Regenerative Processing Plant, LLC
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Dec 10, 2024
FDA report date: Dec 25, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0152-2025 ↗

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