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
- REGENER-EYES (GLYCERIN)
- Brand
- REGENER-EYES
- Manufacturer
- Regenerative Processing Plant, LLC
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- lack-of-sterility
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.
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