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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Regener-Eyes Ophthalmic Solutions Recalled for Lack of Sterility Assurance

Agency Publication Date: December 17, 2024
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Summary

Regenerative Processing Plant, LLC has recalled approximately 230,087 bottles of LITE and PROFESSIONAL Regener-Eyes Ophthalmic Solutions (glycerin eye drops) because they lack sterility assurance. These products are sold in 3mL bottles and were distributed nationwide to consumers needing ocular lubrication. The recall affects 170,812 bottles of the LITE version and 59,275 bottles of the PROFESSIONAL version across many different production batches.

Risk

Eye drops that are not sterile can introduce microorganisms directly into the eye, which may cause serious infections that could lead to vision loss or other permanent damage. While no injuries have been reported to date, any product used in the eyes must be sterile to ensure consumer safety.

What You Should Do

  1. This recall affects LITE (0.4% glycerin) and PROFESSIONAL (0.5% glycerin) Regener-Eyes Ophthalmic Solutions sold in 3mL bottles.
  2. Check your bottles for NDC codes 82305-006-01 (LITE) or 82305-003-01 (PROFESSIONAL) and expiration dates ranging from December 2024 through December 2025. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns or experience unusual eye symptoms after using these drops, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions about this safety notification.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: LITE Regener-Eyes Ophthalmic Solution (3mL)
Variants: glycerin 0.4%
Lot Numbers (90):
P121322A (Exp. 12/13/2024)
P121322B (Exp. 12/13/2024)
P121422A (Exp. 12/14/2024)
P121922A (Exp. 12/19/2024)
P121922B (Exp. 12/19/2024)
P122022A (Exp. 12/20/2024)
P122122A (Exp. 12/21/2024)
P122122B (Exp. 12/21/2024)
P122622A (Exp. 12/26/2024)
P122622B (Exp. 12/26/2024)
P122722A (Exp. 12/27/2024)
P122722B (Exp. 12/27/2024)
P122822A (Exp. 12/28/2024)
P122822B (Exp. 12/28/2024)
P010223A (Exp. 1/2/2025)
P010323LV1 (Exp. 1/3/2025)
P010523A (Exp. 1/5/2025)
P010523B (Exp. 1/5/2025)
P010923A (Exp. 1/9/2025)
P011023LV2 (Exp. 1/10/2025)
P011223A (Exp. 1/12/2025)
P011223B (Exp. 1/12/2025)
P011623A (Exp. 1/16/2025)
P011723LV3 (Exp. 1/17/2025)
P011923A (Exp. 1/19/2025)
P011923B (Exp. 1/19/2025)
P012323A (Exp. 1/23/2025)
P012323B (Exp. 1/23/2025)
P012523A (Exp. 1/25/2025)
P013123A (Exp. 1/31/2025)
P020223A (Exp. 2/2/2025)
P020623A (Exp. 2/6/2025)
P020823A (Exp. 2/8/2025)
P020923A (Exp. 2/9/2025)
P021323A (Exp. 2/13/2025)
P021523A (Exp. 2/15/2025)
P021523B (Exp. 2/15/2025)
P021623A (Exp. 2/16/2025)
P022023A (Exp. 2/20/2025)
P022123A (Exp. 2/21/2025)
P022323A (Exp. 2/23/2025)
P022723A (Exp. 2/27/2025)
P030123A (Exp. 3/1/2025)
P030223A (Exp. 3/2/2025)
P030623A (Exp. 3/6/2025)
P030723A (Exp. 3/7/2025)
P030823A (Exp. 3/8/2025)
P030923A (Exp. 3/9/2025)
P031423A (Exp. 3/14/2025)
P032023A (Exp. 3/20/2025)
NDC:
82305-006-01

Distributed by Regener-Eyes, Tampa, FL.

Product: PROFESSIONAL Regener-Eyes Ophthalmic Solution (3mL)
Variants: glycerin 0.5%
Lot Numbers:
P120522A (Exp. 12/5/2025)
P120522B (Exp. 12/5/2024)
P120822A (Exp. 12/8/2024)
P1208228 (Exp. 12/8/2024)
P121222A (Exp. 12/12/2024)
P1212228 (Exp. 12/12/2024)
P121922A (Exp. 12/19/2024)
P121922B (Exp. 12/19/2024)
P122222A (Exp. 12/22/2024)
P122622A (Exp. 12/26/2024)
P122622B (Exp. 12/26/2024)
P010223A (Exp. 1/2/2025)
P010423PV1 (Exp. 1/4/2025)
P010523A (Exp. 1/5/2025)
P010523B (Exp. 1/5/2025)
P010923A (Exp. 1/9/2025)
P011123PV2 (Exp. 1/11/2025)
P011223A (Exp. 1/12/2025)
P011223B (Exp. 1/12/2025)
P011623A (Exp. 1/16/2025)
P011823PV3 (Exp. 1/18/2025)
P011923A (Exp. 1/19/2025)
P011923B (Exp. 1/19/2025)
P012323A (Exp. 1/23/2025)
P012323B (Exp. 1/23/2025)
P012623A (Exp. 1/26/2025)
P013023A (Exp. 1/30/2025)
P020123A (Exp. 2/1/2025)
P020723A (Exp. 2/7/2025)
P021423 (Exp. 2/14/2025)
P021623A (Exp. 2/16/2025)
P022023A (Exp. 2/20/2025)
P022223A (Exp. 2/22/2025)
P022823A (Exp. 2/28/2025)
P030123A (Exp. 3/1/2025)
P050423A (Exp. 5/4/2025)
P051823A (Exp. 5/18/2025)
P052523A (Exp. 5/25/2025)
NDC:
82305-003-01

Distributed by Regener-Eyes, Tampa, FL.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95912
Status: Resolved
Manufacturer: Regenerative Processing Plant, LLC
Sold By: Regener-Eyes
Manufactured In: United States
Units Affected: 2 products (170812 bottles; 59275)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.