Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Antibiotic Recalls

Recalls of antibiotics used to treat bacterial infections.

197 recalls in this category, newest first.

Class III · Low risk

Clindamycin Phosphate USP

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

Ongoing Impurity / degradation Sun Pharmaceutical Industries INC NDC 51672-4081-4 D-0257-2026
Class II · Moderate risk

Doxycycline Hyclate Tablets

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

Ongoing Dissolution failure Acella Pharmaceuticals, LLC NDC 42192-501-05 D-0014-2026
Class II · Moderate risk

Cephalexin for Oral Suspension

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

Ongoing Impurity / degradation Ascend Laboratories, LLC NDC 67877-544-68 D-0469-2025
Class II · Moderate risk

Cephalexin for Oral Suspension

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

Ongoing Impurity / degradation Ascend Laboratories, LLC NDC 67877-544-88 D-0468-2025
Class II · Moderate risk

Clindamycin HCl Capsule

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Ongoing cGMP deviation RemedyRePack Inc. D-0411-2025
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-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
Class III · Low risk

Cephalexin for Oral Suspension

Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

Ongoing Labeling / mix-up Bryant Ranch Prepack, Inc. NDC 63629-9207-1 D-0540-2024
Class III · Low risk

Cephalexin for Oral Suspension

Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'

Ongoing Labeling / mix-up Bryant Ranch Prepack, Inc. NDC 63629-9206-1 D-0539-2024