Prescription ciprofloxacin eye drops recalled for temperature abuse manufacturing deviation
McKesson Medical-Surgical is recalling Ciprofloxacin Hydrochloride 0.3% ophthalmic solution nationwide due to temperature abuse, a cGMP violation that may compromise product integrity.
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 recall involving manufacturing deviations (cGMP temperature abuse) of a prescription drug. Although no illnesses or injuries have been reported, the manufacturing deviation presents a risk of compromised drug efficacy and safety. Score reflects potential risk without documented patient harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ciprofloxacin Hydrochloride (Ciprofloxacin HCl) 0.3% ophthalmic solution in 5 mL bottles, a prescription antibiotic eye drop. The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. Approximately 7 bottles were distributed nationwide in the USA.
Temperature abuse is a manufacturing deviation that may affect the stability and integrity of the product. McKesson Medical-Surgical is unable to identify specific lot numbers for products received by individual customers. Each recall letter will include the dates the affected product may have been shipped to that customer.
Patients should contact their healthcare provider or pharmacy to determine if their supply is affected and discuss treatment options. Healthcare providers and distributors who received this product should verify their distribution records against recall information and follow all recall instructions provided by McKesson Medical-Surgical.
The recalled product
- Product
- CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE)
- Brand
- CIPROFLOXACIN HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0361314656100
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.
See all 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- HighProparacaine Hydrochloride Eye Drops Recalled Due to Temperature Exposure
FDA (Drugs) · 2024-10-02
- ModerateCardinal Health Recalls Ciprodex Eye Drops Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateCardinal Health Recalls Ofloxacin Eye Drops Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateCiprofloxacin ophthalmic solution recalled for manufacturing practice deviations
FDA (Drugs) · 2023-01-25
- ModerateMcKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2017-04-19
- ModerateFDA Recalls SYSTANE Lubricant Eye Drops Due to Improper Storage
FDA (Drugs) · 2022-08-17