Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 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 II · Moderate risk

Captopril Tablets

Failed Tablet/Capsule Specifications: out of specification for thickness.

Terminated Failed specification Wockhardt Usa Inc. NDC 64679-902-01 D-0975-2015
Class II · Moderate risk

Domperidone BP

Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.

Terminated Cross-contamination Freedom Pharmaceuticals Inc D-0567-2016
Class II · Moderate risk

Ergoloid Mesylates

Failed Impurities/Degradation Specifications: during long-term stability testing.

Terminated Impurity / degradation Mutual Pharmaceutical Company, Inc. NDC 53489-281-01 D-0414-2015
Class II · Moderate risk

Triest 80/10/10

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0228-2016
Class II · Moderate risk

Triest 80/10/10

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0227-2016
Class II · Moderate risk

Triest 70/20/10

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0226-2016
Class II · Moderate risk

Estriol 5 Estradiol

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0225-2016
Class II · Moderate risk

ESTRIOL (weight/volume)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0224-2016
Class II · Moderate risk

ESTRIOL (weight/volume)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0223-2016
Class II · Moderate risk

ESTRIOL (weight/volume)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0222-2016
Class II · Moderate risk

Estriol

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0221-2016
Class II · Moderate risk

ESTRIOL (Testosterone USP)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0220-2016
Class II · Moderate risk

ESTRIOL (Estradiol (E2)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0219-2016
Class II · Moderate risk

ESTRIOL (Estradiol (E2)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0218-2016
Class II · Moderate risk

ESTRIOL (Estradiol (E2)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0217-2016
Class II · Moderate risk

ESTRIOL (weight/volume)

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0216-2016
Class II · Moderate risk

Estriol

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0214-2016
Class II · Moderate risk

E2 (Estradiol

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0213-2016
Class II · Moderate risk

Biest Td 91/9

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Terminated Cross-contamination the Compounder D-0212-2016

Recalls by year