Class IITerminated
LITE Regener-Eyes recall
FDA recall D-0152-2025 · initiated Dec 10, 2024
By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Dec 25, 2024How we research
Regenerative Processing Plant, LLC recalled LITE Regener-Eyes in Dec 2024 — an FDA Class II recall (D-0152-2025) because Lack of Sterility Assurance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Sterility Assurance
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Lot #: P121322A, P121322B, Exp. Date 12/13/2024; P121422A, Exp. Date 12/14/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122022A, Exp. Date 12/20/2024; P122122A, P122122B, Exp. Date 12/21/2024; P122622A, P122622B, Exp. Date 12/26/2024; P122722A, P122722B, Exp. Date 12/27/2024; P122822A, P122822B, Exp. Date 12/28/2024. P010223A, Exp. Date 1/2/2025; P010323LV1, Exp. Date 1/3/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011023LV2, Exp. Date 1/10/2025, P011223A, P011223B, Exp. Date 1/12/2025; P011623A; Exp. Date 1/16/2025, P011723LV3, Exp. Date 1/17/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012523A, Exp. Date 1/25/2025; P013123A, Exp. Date 1/31/2025; P020223A, Exp. Date 2/2/2025; P020623A, Exp. Date 2/6/2025,P020823A, Exp. Date 2/8/2025, P020923A, Exp. Date 2/9/2025, P021323A, Exp. Date 2/13/2025; P021523A, P021523B, Exp. Date 2/15/2025, P021623A, Exp. Date 2/16/2025, P022023A, Exp. Date 2/20/2025, P022123A, Exp. Date 2/21/2025, P022323A, Exp. Date 2/23/2025, P022723A, Exp. Date 2/27/2025, P030123A, Exp. Date 3/1/2025, P030223A, Exp. Date 3/2/2025, P030623A, Exp. Date 3/6/2025; P030723A, Exp. Date 3/7/2025; P030823A, Exp. Date 3/8/2025; P030923A Exp. Date 3/9/2025, P031423A, Exp. Date 3/14/2025, P032023A, Exp. Date 3/20/2025, P032123A, Exp. Date 3/21/2025; P032223A, Exp. Date 3/22/2025; P032723A, Exp. Date 3/27/2025; P040423A, Exp. Date 4/4/2025; P040523A, Exp. Date 4/5/2025; P040623A, Exp. Date 4/6/2025; P041023A, Exp. Date 4/10/2025;P041123A, Exp. Date 4/11/2025; P041223A, Exp. Date 4/12/2025; P041323A, Exp. Date 4/13/2025; P041723A, Exp. Date 4/17/2025; P041823A, Exp. Date 4/18/2025;P041923A, Exp. Date 4/19/2025; P042023A, Exp. Date 4/20/2025; P042423A, Exp. Date 4/24/2025; P042523A, Exp. Date 4/25/2025;P042623A, Exp. Date 4/26/2025; P050323A, Exp. Date 5/3/2025; P050823A, Exp. Date 5/8/2025;P050923A, Exp. Date 5/9/2025;P051023A, Exp. Date 5/10/2025;P051123A, Exp. Date 5/11/2025;P051523A, Exp. Date 5/15/2025; P051623A, Exp. Date 5/16/2025; P051723A, Exp. Date 5/17/2025; P052223A, Exp.: 5/22/2025; P052323A, Exp.: 5/23/2025; P052423A, Exp. Date 5/24/2025; P052523A, Exp.: 5/25/2025; P053023A, Exp. Date 5/30/2025; P053123A, Exp. Date 5/31/2025; P060123A, Exp. Date 6/1/2025; P060223A, Exp. Date 6/2/2025; P060523A, Exp. Date 6/5/2025; P060623A, Exp. Date 6/6/2025; P060723A, Exp. Date 6/7/2025; P060823A, Exp. Date 6/8/2025; P061223A, Exp. Date 6/12/2025; P061323A, Exp. Date 6/13/2025; P061423A, Exp. Date 6/14/2025
Quantity recalled: 170812 bottles
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
Frequently asked
- Was LITE Regener-Eyes recalled?
- Regenerative Processing Plant, LLC recalled LITE Regener-Eyes in Dec 2024 — an FDA Class II recall (D-0152-2025) because Lack of Sterility Assurance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was LITE Regener-Eyes recalled?
- Per the FDA enforcement record, the reason for recall D-0152-2025 was: Lack of Sterility Assurance
- Is a recalled LITE Regener-Eyes dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of LITE Regener-Eyes are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: P121322A, P121322B, Exp. Date 12/13/2024; P121422A, Exp. Date 12/14/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122022A, Exp. Date 12/20/2024; P122122A, P122122B, Exp. Date 12/21/2024; P122622A, P122622B, Exp. Date 12/26/2024; P122722A, P122722B, Exp. Date 12/27/2024; P122822A, P122822B, Exp. Date 12/28/202…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0152-2025.