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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
- Manufacturer
- Regenerative Processing Plant, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 59,275
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.
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
See all →- HighOphthalmic solution recalled for lack of sterility assurance
FDA (Drugs) · 2024-12-25
Same hazard · lack of sterility
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