Moderate riskFDA DrugNov 3, 2026Class II

Hikma ciprofloxacin 500 mg tablets recalled for N-nitroso impurity

Hikma Pharmaceuticals USA Inc. is recalling 29,085 bottles of Ciprofloxacin Tablets, USP, 500 mg, 100-count. The FDA found N-nitroso-ciprofloxacin levels above its recommended interim control limit, a problem under current good manufacturing practice (CGMP) rules. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Hikma Pharmaceuticals recalls

What to do

Talk to your pharmacist or prescriber before stopping this medicine.
Check the bottle for lot numbers CB496A, CB497A or CB498A, expiration date 12/31/2026, and NDC 0143-9928-01.
The notice doesn't say how to get a refund or replacement; contact Hikma Pharmaceuticals USA Inc. or the pharmacy where you bought it.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Ciprofloxacin Tablets, USP, 500 mg, 100-count bottle, Rx Only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 182400, Amman, 11118-Jordan, Distributed by: Hikma Pharmaceuticals USA Inc. Berkely Heights, NJ 07922, NDC 0143-9928-01
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 29,085 bottles
Illnesses reported: None reported
Manufactured in: 1809 Wilson Rd, Columbus, Ohio, United States
Classification: Class II
Recall number: D-0165-2027

In the FDA's words

Description: Ciprofloxacin Tablets, USP, 500 mg, 100-count bottle, Rx Only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 182400, Amman, 11118-Jordan, Distributed by: Hikma Pharmaceuticals USA Inc. Berkely Heights, NJ 07922, NDC 0143-9928-01 CGMP Deviations: N-nitroso-ciprofloxacin results above the FDA recommended interim control limit. Lot# CB496A; Exp. 12/31/2026 Lot# CB497A; Exp. 12/31/2026 Lot# CB498A; Exp. 12/31/2026 Distribution: US Nationwide Affected quantity: 29,085 bottles
Hazard: CGMP Deviations: N-nitroso-ciprofloxacin results above the FDA recommended interim control limit.

2 products in this recall

The agency lists each product separately. Check every one you might have.

Ciprofloxacin Tablets, USP, 500 mg, 100-count bottle, Rx Only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 182400, Amman, 11118-Jordan, Distributed by:… (this page)
D-0165-2027 · 29,085 bottles
Ciprofloxacin Tablets, USP, 750 mg, 50-count bottle, Rx Only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 182400, Amman, 11118-Jordan, Distributed by: H…
D-0166-2027 · 20,335 bottles