49,420 Bottles of a Common Antibiotic Recalled: Check These 6 Lots

49,420 Bottles of a Common Antibiotic Recalled: Check These 6 Lots

Direct answer: The U.S. Food and Drug Administration (FDA) classified a Class II recall of 49,420 bottles of the antibiotic ciprofloxacin on November 3, 2026, after tests found levels of a nitrosamine impurity above the FDA-recommended limit. Only six lots are affected — three lots of 500 mg tablets and three lots of 750 mg tablets, all expiring December 31, 2026. If your bottle matches one of those lots, contact your pharmacist to check — and do not stop a prescribed antibiotic on your own.

What was recalled?

The recall covers ciprofloxacin tablets made by Hikma Pharmaceuticals and distributed in the United States by Hikma Pharmaceuticals USA Inc. 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.

The FDA reason is listed as “N-nitroso-ciprofloxacin results above the FDA-recommended interim control limit.” The FDA classified the recall as Class II on November 3, 2026 (recall numbers D-0165-2027 and D-0166-2027). A Class II recall means use of the product may cause temporary or medically reversible health consequences, or that the probability of serious harm is remote, according to the FDA definition.

N-nitroso-ciprofloxacin is a type of nitrosamine, an impurity also found in water and some foods. The FDA sets limits on nitrosamines in medicines to help keep potential health risks low. 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.

Which lots should you check?

Strength	Bottle size	Lot numbers	NDC	Bottles recalled	Expiration
500 mg	100 tablets	CB496A, CB497A, CB498A	0143-9928-01	29,085	Dec 31, 2026
750 mg	50 tablets	CA083A, CA084A, CA085A	0143-9929-50	20,335	Dec 31, 2026

The recalled bottles were distributed nationwide in the United States. Check three things on your bottle: the medicine name, the manufacturer (Hikma), and the lot number.

Is my bottle affected if it looks different?

Only the six lots above are in scope. If your bottle shows a different lot number, a different manufacturer, or a different strength or bottle size, it is not part of this recall listing. One practical catch: if your medicine was transferred into a plain pharmacy bottle, the manufacturer lot number may not appear on the label. In that case, call the pharmacy that filled the prescription and ask whether your medicine came from one of the recalled lots.

The recall is limited to the wholesale, distributor, and retail pharmacy levels, according to the notice published by the California State Board of Pharmacy. A medical assessment of the affected lots concluded that the observed N-nitroso-ciprofloxacin levels are “not expected to adversely impact patient safety.”

What should you do if your lot matches?

• Contact your pharmacist or prescribing clinician and ask what to do next.
• Ask whether to keep taking the medicine while a replacement is arranged.
• Follow any return or disposal instructions your pharmacy provides.
• Do not stop a prescribed antibiotic without first talking to your doctor or pharmacist — stopping an antibiotic early can carry its own risks, and the FDA notes that patients can generally continue using a medicine in a Class II recall unless the company or the agency directs otherwise.

How is this different from other recent recalls?

Not every recall means contamination. This one is about an impurity found above the FDA's interim limit, not a reported contamination finding, and not a tablet that fails to dissolve. It is also narrow: 49,420 bottles in six lots, rather than every bottle of this antibiotic on the market. That is why the lot number — not just the medicine name — is the deciding detail.

Frequently asked questions

Is all ciprofloxacin recalled?
No. The FDA listing covers only the six Hikma lots above. Other manufacturers' ciprofloxacin, and other Hikma lots, are not part of this recall.

Does a Class II recall mean the medicine is dangerous?
Class II is the FDA's middle severity tier. It means temporary or reversible health consequences are possible, while the probability of serious harm is remote. It is not a reason to change your routine without professional guidance.

What if I already took tablets from one of these lots?
Talk to your pharmacist or prescriber about it. The medical assessment published with the recall notice concluded the observed impurity levels are not expected to adversely impact patient safety. You can also report a medication-quality problem through the FDA MedWatch program or by calling 800-FDA-1088.

Where can I verify this myself?
Search the FDA Enforcement Reports for recall numbers D-0165-2027 and D-0166-2027, or check the lot number and NDC on your bottle against the table above.

Key Takeaway

Check the lot number, not just the medicine name: only six Hikma ciprofloxacin lots (49,420 bottles, expiring December 31, 2026) are recalled, and your pharmacist is the right first call if yours matches.

Sources: FDA Enforcement Report, Event 100142, recalls D-0165-2027 and D-0166-2027, Class II classified November 3, 2026; The Healthy, “FDA: Nearly 50,000 Bottles of Common Antibiotic Recalled Nationwide,” November 4, 2026; California State Board of Pharmacy recall notice, Hikma Pharmaceuticals USA Inc. ciprofloxacin tablets.

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This post was created with the help of AI tools and reviewed for accuracy against the sources cited above. It is general information only, not medical advice. For decisions about your own medicine, please talk to your doctor or pharmacist.