Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Apr 9, 2012 (15 years ago)

Dr. Reddy's Ciprofloxacin Tablets

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

Why it was recalled

Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets

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

Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05

Affected NDC 55111-0127-05

Compare with the code on your package — it is the most precise check available.

Drug: Ciprofloxacin Category: Antibiotic

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-127-05
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1435-2012 · 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 Dr. Reddy's Laboratories, Inc.

All 2012 recalls
Class III · Low risk

Varenicline Tablets

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Ongoing Wrong potency / content Dr. Reddy's Laboratories, Inc. NDC 43598-908-56 D-0219-2026
Class II · Moderate risk

Omeprazole Delayed-release Capsules

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Ongoing Particulate / foreign matter Dr. Reddy's Laboratories, Inc. NDC 82009-022-10 D-0525-2025
Class I · High risk

Levetiracetam 0.75% in Sodium Chloride Injection 1

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Ongoing Labeling / mix-up Dr. Reddy's Laboratories, Inc. NDC 43598-636-52 D-0365-2025