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

1,525 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

Good to Go Hand Sanitizer

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Terminated Stability / shelf life NingBo Huize Commodity Co.,Ltd. D-1530-2019
Class III · Low risk

Clonidine HCL Injection

Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.

Terminated Labeling / mix-up X-Gen Pharmaceuticals Inc. NDC 39822-2000-1 D-1084-2019
Class III · Low risk

Nystatin Oral Suspension

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Terminated Impurity / degradation Akorn, Inc. NDC 50383-587-16 D-1080-2019
Class III · Low risk

Diclofenac Sodium Topical Solution

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Terminated Packaging defect Ingenus Pharmaceuticals Llc NDC 50742-308-05 D-1058-2019
Class III · Low risk

Clindamycin Injection

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Terminated Impurity / degradation Pfizer Inc. NDC 47781-621-94 D-1072-2019
Class III · Low risk

Clindamycin Injection

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Terminated Impurity / degradation Pfizer Inc. NDC 47781-620-94 D-1071-2019
Class III · Low risk

Clindamycin Injection

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Terminated Impurity / degradation Pfizer Inc. NDC 47781-619-94 D-1070-2019
Class III · Low risk

Cleocin Phosphate

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Terminated Impurity / degradation Pfizer Inc. NDC 0009-3447-01 D-1069-2019
Class III · Low risk

Cleocin Phosphate

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Terminated Impurity / degradation Pfizer Inc. NDC 0009-3124-01 D-1068-2019
Class III · Low risk

Cleocin Phosphate

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Terminated Impurity / degradation Pfizer Inc. NDC 0009-6582-02 D-1067-2019
Class III · Low risk

Testosterone Topical Solution

Defective Container: Repetitive complaints received indicating pump not working.

Terminated Packaging defect Lupin Pharmaceuticals Inc. NDC 68180-943-11 D-1010-2019
Class III · Low risk

Mirapex (pramipexole dihydrochloride)

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

Terminated Failed specification Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0190-61 D-0991-2019

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