FDA Drug recall D-0153-2025

PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL

FDA Drug
Class II
terminated
Published 2024-12-25

On 2024-12-25 the FDA classified a Class II recall of PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL by Regenerative Processing Plant, citing lack of Sterility Assurance.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0153-2025
Classification	Class II
Status	terminated
Initiated	2024-12-10
Published	2024-12-25
Last updated	2026-09-13 11:52 UTC
Company	Regenerative Processing Plant
Distribution	US

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

Lack of Sterility Assurance

Identifiers

code_info	Lot #: P120522A, Exp. Date 12/5/2025, P120522B, Exp. Date 12/5/2024; P120822A, Exp. Date 12/8/2024; P1208228, Exp. Date… 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

code_info

Lot #: P120522A, Exp. Date 12/5/2025, P120522B, Exp. Date 12/5/2024; P120822A, Exp. Date 12/8/2024; P1208228, Exp. Date…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0153-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.