Multi-event December 2024 FDA Recall Regener-eyes by Regenerative Processing Plant, Llc

This Multi-event Class II drug recall was voluntarily initiated by Regenerative Processing Plant, Llc on December 10, 2024 for the product Regener-eyes. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0152-2025 TERMINATED D-0153-2025 TERMINATED

Recall Number: D-0152-2025

Reason for Recall
Lack of Sterility Assurance
Initiated
12-10-2024
Reported
12-25-2024
Quantity
170812 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95912
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Regenerative Processing Plant, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-27-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

82305-006-01 Regener-eyes Lite
82305-006-02 Regener-eyes Lite

Recall Number: D-0153-2025

Reason for Recall
Lack of Sterility Assurance
Initiated
12-10-2024
Reported
12-25-2024
Quantity
59275

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95912
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Regenerative Processing Plant, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-27-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : P120522A, Exp. Date 12/5/2025, P120522B, Exp. Date 12/5/2024; P120822A, Exp. Date 12/8/2024; P1208228, Exp. Date 12/8/2024; P121222A, P1212228, Exp. Date 12/12/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122222A, Exp. Date 12/22/2024; P122622A, P122622B, Exp. Date 12/26/2024; P010223A, Exp. Date 1/2/2025; P010423PV1, Exp. Date 1/4/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011123PV2, Exp. Date 1/11/2025; P011223A, P011223B, Exp. Date 1/12/2025; P011623A, Exp. Date 1/16/2025; P011823PV3, Exp. Date 1/18/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012623A, Exp. Date 1/26/2025; P013023A, Exp. Date 1/30/2025; P020123A, Exp. Date 2/1 /2025; P020723A, Exp. Date 2/7/2025; P021423, Exp. Date 2/14/2025, P021623A, Exp. Date 2/16/2025; P022023A, Exp. Date 2/20/2025; P022223A, Exp. Date 2/22/2025; P022823A, Exp. Date 2/28/2025; P030123A, Exp. Date 3/1/2025; P050423A, Exp. Date 5/4/2025, P051823A, Exp. Date 5/18/2025, P052523A, Exp. Date 5/25/2025

Affected Packages Involved in this Recall

82305-003-01 Regener-eyes Pro
82305-003-02 Regener-eyes Pro