The Recall Desk
HighFDA (Drugs)·D-0153-2025·Announced 2024-12-25

OTC Ophthalmic Solution Recalled for Lack of Sterility Assurance

REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.

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: This is a risk-of-harm product (ophthalmic solution requiring sterility) with no reported illnesses or injuries. FDA Class II without reported hospitalizations does not meet the Severe threshold but qualifies as High per the rubric.

Plain-English summary

REGENER-EYES ophthalmic solution (glycerin 0.5%), manufactured by Regenerative Processing Plant, LLC and distributed by Regener-Eyes (Tampa, FL), is being recalled due to lack of sterility assurance. The recall affects 59,275 bottles distributed nationwide.

Affected lots include P120522A, P120522B, P120822A, P1208228, P121222A, P1212228, P121922A, P121922B, P122222A, P122622A, P122622B, P010223A, P010423PV1, P010523A, P010523B, P010923A, P011123PV2, P011223A, P011223B, P011623A, P011823PV3, P011923A, P011923B, P012323A, P012323B, P012623A, P013023A, P020123A, P020723A, P021423, P021623A, P022023A, P022223A, P022823A, P030123A, P050423A, P051823A, and P052523A, with expiration dates ranging from December 2024 through May 2025.

Consumers should immediately stop using any affected lot and consult with their healthcare provider regarding prior use of the recalled product.

The recalled product

Product
REGENER-EYES (REGENER-EYES)
Brand
REGENER-EYES
Manufacturer
Regenerative Processing Plant, LLC
Category
Drug — Ophthalmic Solution
Hazard
  • lack-of-sterility
  • infection-risk

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 #: P120522A
  • Exp. Date 12/5/2025
  • P120522B
  • Exp. Date 12/5/2024
  • P120822A
  • Exp. Date 12/8/2024
  • P1208228
  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · REGENER-EYES

Same category