FDA recall, , Moderate risk
Hikma Ciprofloxacin Tablets
Ciprofloxacin Tablets have N-nitroso-ciprofloxacin results above the FDA recommended interim control limit.
Summary by Recall Canary from the FDA notice
What happened
Hikma Pharmaceuticals USA INC., located in Columbus, Ohio, voluntarily recalled Ciprofloxacin Tablets, USP, because N-nitroso-ciprofloxacin results were above the FDA recommended interim control limit. The recall began on October 20, 2026, and was classified by the FDA on November 3, 2026. The products were distributed nationwide.
The recalled products include Ciprofloxacin Tablets, USP, 750 mg, 50-count bottles, and Ciprofloxacin Tablets, USP, 500 mg, 100-count bottles. Customers were notified by letter.
2 photos
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Ciprofloxacin Tablets, USP
- Strength
- 750 mg
- NDC
- 0143-9929-50
- Lot code
- CA083A
- CA084A
- CA085A
- Strength
- 500 mg
- NDC
- 0143-9928-01
- Lot code
- CB496A
- CB497A
- CB498A
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
US Nationwide
- Recalled by
- Hikma Pharmaceuticals USA INC.Columbus, Ohio
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100142
- Recall numbers
- D-0165-2027 to D-0166-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Hikma Pharmaceuticals USA INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Hikma Pharmaceuticals USA INC. began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
