FDA-Drug2024-12-25Class II

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

Regenerative Processing Plant, LLC
Hazard

Lack of Sterility Assurance

Sold states
Nationwide within the United States
Affected count
170812 bottles
Manufactured in
34176 Us Highway 19 N, Palm Harbor, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0152-2025

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief