In the agency's Nov 11, 2026 enforcement report · Ongoing
Ciprofloxacin Tablets, USP, 500 mg, 100-count bottle, Rx Only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 182400,…
Hikma Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Pharmaceuticals USA INC. · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Ciprofloxacin Tablets, USP, 500 mg, 100-count bottle, Rx Only
- Manufactured byHikma Pharmaceuticals, P.O. Box 182400, Amman, 11118-Jordan
- Distributed byHikma Pharmaceuticals USA Inc. Berkely Heights, NJ 07922, NDC 0143-9928-01
- Lot codes and dates
Lot# CB496AExp. 12/31/2026 Lot# CB497AExp. 12/31/2026 Lot# CB498AExp. 12/31/2026
- Amount recalled
- 29,085 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: N-nitroso-ciprofloxacin results above the FDA recommended interim control limit.
This product could cause temporary or reversible health problems — stop using it.
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