The Recall Desk
HighFDA (Drugs)·D-0152-2025·Announced 2024-12-25

Ophthalmic solution recalled for lack of sterility assurance

Regener-Eyes ophthalmic solution is being recalled due to lack of sterility assurance. Approximately 170,812 bottles distributed nationwide are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for lack of sterility assurance in an ophthalmic solution. This is a risk-of-harm product without reported injuries, fitting the High severity criteria.

Plain-English summary

REGENER-EYES ophthalmic solution (glycerin 0.4%) is being recalled due to lack of sterility assurance. The recall is nationwide and affects approximately 170,812 bottles distributed across multiple lots with expiration dates from December 2024 through June 2025.

A lack of sterility assurance in an ophthalmic solution poses a risk of microbial contamination. Consumers who have used the affected product and experience eye irritation or other symptoms should contact their healthcare provider.

Consumers should discontinue use of this product immediately if they possess bottles from the affected lots. For specific lot numbers and expiration dates, or to arrange return or replacement, contact the manufacturer, Regenerative Processing Plant, LLC, or consult with your pharmacy or eye care provider.

The recalled product

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
Manufacturer
Regenerative Processing Plant, LLC
Category
Drug — Ophthalmic / Eye Care
Hazard
Affected units
170,812

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Regenerative Processing Plant, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Regenerative Processing Plant, LLC

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Same hazard · lack of sterility

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