Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class II · Moderate risk Terminated Initiated May 22, 2014 (12 years ago)

Ciprofloxacin 500 mg tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India

Drug: Ciprofloxacin Category: Antibiotic

Recalling firm
Aidarex Pharmaceuticals LLC
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0042-2015 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Ciprofloxacin recalls

See all
Class II · Moderate risk

Ciprofloxacin Ophthalmic Solution USP

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Ongoing Packaging defect FDC Limited NDC 69315-308-05 D-0282-2025
Class II · Moderate risk

Ciprofloxacin Ophth Solution

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Ongoing Packaging defect Direct Rx NDC 61919-795-05 D-0364-2025
Class II · Moderate risk

Ciprofloxacin Ophthalmic Solution USP

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Ongoing Packaging defect FDC Limited NDC 69315-308-05 D-0182-2025
Class II · Moderate risk

Ciprofloxacin ophthalmic solution USP

Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Ongoing Packaging defect FDC Limited NDC 69315-308-10 D-0623-2024

Other recalls by Aidarex Pharmaceuticals LLC

All 2014 recalls
Class III · Low risk

Enalapril Maleate

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Terminated Impurity / degradation Aidarex Pharmaceuticals LLC D-0992-2018
Class III · Low risk

Enalapril Maleate

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Terminated Impurity / degradation Aidarex Pharmaceuticals LLC D-0991-2018
Class III · Low risk

Enalapril Maleate

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Terminated Impurity / degradation Aidarex Pharmaceuticals LLC D-0990-2018