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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95912

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 10, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Regenerative Processing Plant, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0152-2025
Recall number
D-0152-2025
Initiated
December 10, 2024
Classification
Class II
Status
Terminated
Quantity
170812 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

Code 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

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

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

D-0153-2025
Recall number
D-0153-2025
Initiated
December 10, 2024
Classification
Class II
Status
Terminated
Quantity
59275

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

Code 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

Distribution pattern

Nationwide within the United States

Field note

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