Prescription Drug Recall: Betadine Sterile Ophthalmic Solution Due to Temperature Abuse
McKesson Medical-Surgical is recalling Betadine 5% Sterile Ophthalmic Prep Solution nationwide due to manufacturing deviations involving temperature abuse during production.
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: FDA Class II classification applied; temperature abuse of sterile ophthalmic solution presents a documented risk to product sterility and stability. No illnesses or injuries have been reported. Meets criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Betadine 5% Sterile Ophthalmic Prep Solution (povidone-iodine), a prescription ophthalmic antiseptic manufactured for Alcon Surgical Inc. The recalled product is supplied in 1 fl. oz. (30 mL) bottles, with approximately 799 cartons distributed.
The recall is due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing. The products were exposed to temperature abuse during production, which may affect the sterility and stability of the ophthalmic solution.
The affected product was distributed nationwide throughout the United States. The manufacturer was unable to identify the specific lot numbers distributed to each recipient; notification letters sent to customers include the dates products were shipped.
Recipients of the recalled product should verify their inventory against the recall notice. Healthcare providers and patients with questions should contact their supplier or healthcare provider.
The recalled product
- Product
- BETADINE (POVIDONE-IODINE)
- Brand
- BETADINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic Preparation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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.
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