Nearly 50,000 bottles of a common antibiotic recalled nationwide over impurity
Editorial illustration — Press Pass USAHikma Pharmaceuticals USA Inc. of Columbus, Ohio, is recalling 49,420 bottles of the antibiotic ciprofloxacin nationwide after tests found levels of a nitrosamine impurity above the limit recommended by the U.S. Food and Drug Administration. The FDA assigned the recall a Class II risk level on November 3.
The recall covers six lots of ciprofloxacin tablets: 29,085 bottles of the 500-milligram tablets in 100-count bottles, and 20,335 bottles of the 750-milligram tablets in 50-count bottles. The affected lots are CB496A, CB497A and CB498A for the 500-milligram strength, and CA083A, CA084A and CA085A for the 750-milligram strength, all with an expiration date of December 31, 2026.
The recall was triggered by results for N-nitroso-ciprofloxacin, a type of nitrosamine impurity, above the FDA's recommended interim control limit. Nitrosamines are impurities found in some medications — and also in water and certain foods — and the FDA sets limits on them in medicines to minimize potential health risks. Some nitrosamine impurities may increase cancer risk when people are exposed to levels above acceptable limits over long periods of time, though not all nitrosamines carry the same risk, according to the FDA.
A Class II recall means a product may cause temporary health issues, but the probability of serious adverse effects is remote, under the FDA's definitions. A medical assessment of the affected lots concluded that the observed levels of N-nitroso-ciprofloxacin are not expected to adversely impact patient safety, and all other testing parameters for the lots were within specification, according to a recall notice published by the California State Board of Pharmacy.
The recall is limited to the wholesale, distributor and retail pharmacy levels. Patients who currently take prescription ciprofloxacin should contact their pharmacist to determine whether their medication is affected by the recall.
Ciprofloxacin is a prescription antibiotic used to treat a range of bacterial infections, including urinary tract infections, kidney infections, certain gastrointestinal infections and some respiratory infections.
Sources: The Healthy, “FDA: Nearly 50,000 Bottles of Common Antibiotic Recalled Nationwide” (Nov. 4, 2026); California State Board of Pharmacy, recall notice for Hikma Pharmaceuticals USA Inc. ciprofloxacin tablets; U.S. Food and Drug Administration, Enforcement Report (Class II assigned Nov. 3, 2026).
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