Proparacaine Hydrochloride Eye Drops Recalled Due to Temperature Exposure
McKesson Medical-Surgical is recalling 27 bottles of Proparacaine Hydrochloride ophthalmic solution (lots 476261, 479751, 479741) due to temperature abuse that may have compromised sterility. Product was distributed to medical facilities in Maryland and Virginia.
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 (sterile ophthalmic solution) where no illnesses or injuries have been reported. Temperature abuse of a sterile eye drop could compromise sterility or efficacy, creating a potential safety risk that justifies a High severity designation.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, a sterile prescription eye anesthetic, due to temperature abuse. A total of 27 bottles (15 mL each) are affected.
The recalled product was exposed to temperatures above the specifications listed on the drug label. This temperature exposure may have compromised the sterility and safety of the solution. The affected lots are 476261, 479751, and 479741, all with an expiration date of March 31, 2026.
The product was distributed to two medical facilities in Maryland and Virginia. No illnesses or injuries have been reported. Healthcare providers and patients should contact their healthcare provider or pharmacist if they have concerns about the affected product.
The recalled product
- Product
- PROPARACAINE HYDROCHLORIDE (PROPARACAINE HYDROCHLORIDE)
- Brand
- PROPARACAINE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Affected units
- 27
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 (4)
- Lot # 476261
- 479751
- 479741
- Exp 3/31/2026
Distribution
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