Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III drug recalls - low risk

Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.

1,716 recalls, 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

Grapefruit anti bac Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-359-2014
Class III · Low risk

Lemon anti bac Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-358-2014
Class III · Low risk

I love to shop Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-357-2014
Class III · Low risk

I love sleep overs Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-356-2014
Class III · Low risk

I love my BFF Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-355-2014
Class III · Low risk

LIFE IS SWEET! Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-354-2014
Class III · Low risk

TODAY IS AWESOME! Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-353-2014
Class III · Low risk

FOLLOW YOUR DREAMS! Justice

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-352-2014
Class III · Low risk

Girls can change the World

Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.

Terminated Labeling / mix-up Tween Brands Inc D-351-2014
Class III · Low risk

Amoxicillin for Oral Suspension

Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

Terminated Failed specification Teva Pharmaceuticals USA, Inc. NDC 0093-4160-78 D-803-2013
Class III · Low risk

Prednisone Tablet USP

Labeling: Missing Label; missing label on blister card

Terminated Labeling / mix-up Boehringer Ingelheim Roxane Inc NDC 0054-0018-20 D-882-2013
Class III · Low risk

Medroxyprogesterone acetate

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Terminated Stability / shelf life Bayer HealthCare Pharmaceuticals Inc. D-807-2013
Class III · Low risk

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)

Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.

Terminated Dissolution failure Pfizer Inc. NDC 0046-0975-11 D-631-2013
Class III · Low risk

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)

Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.

Terminated Dissolution failure Pfizer Inc. NDC 0046-0875-11 D-630-2013
Class III · Low risk

Norpace CR

Failed Dissolution Specification

Terminated Dissolution failure Pfizer Inc NDC 0025-2742-31 D-607-2013
Class III · Low risk

Excedrin

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2062-02 D-744-2014
Class III · Low risk

Theraflu Warming Relief

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-6438-08 D-742-2014

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