Ciprofloxacin eye drops recalled due to manufacturing temperature deviations
McKesson is recalling Ciprofloxacin Ophthalmic Solution 0.3% nationwide due to temperature deviations during manufacturing. The FDA classifies this as a Class II recall.
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: This is a Class II FDA recall of a prescription medication with manufacturing deviations. While no illnesses or injuries have been reported, Class II recalls indicate potential for adverse health consequences. The actual harm remains theoretical without reported incidents.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ciprofloxacin Ophthalmic Solution 0.3% distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process.
The affected product is a 10 mL bottle of Ciprofloxacin Ophthalmic Solution 0.3%, a prescription antibiotic eye medication manufactured by Alcon Laboratories, Inc. (NDC 61314-0656-10). The product was distributed nationwide through McKesson Medical-Surgical.
The FDA has classified this as a Class II recall. McKesson is unable to identify specific lot numbers affected, but customers have been provided with distribution dates relevant to their shipments.
Patients who may have received this medication should consult with their pharmacy or prescriber to determine if their product is affected and whether a replacement prescription is needed.
The recalled product
- Product
- Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27