Independent register of U.S. FDA drug recalls · updated Oct 14, 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.

14,543 recalls, newest first.

Class II · Moderate risk

Doctor Manzanilla Cough & Cold

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Terminated Microbial contamination Mid Valley Pharmaceutical D-1136-2017
Class II · Moderate risk

Ketorolac Trom 30 mg/mL Injection

Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.

Terminated Failed specification RemedyRepack Inc. NDC 61786-0741-01 D-1176-2017
Class II · Moderate risk

HYDROmorphone HCl Injection

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Terminated Sterility / contamination Pfizer Inc. NDC 0409-3365-11 D-1167-2017
Class II · Moderate risk

Ninjacof-A

Microbial contamination of Non-sterile Products; potential B. cepacia contamination

Terminated Microbial contamination Centurion Labs, LLC NDC 23359-033-16 D-1141-2017
Class II · Moderate risk

Nose to Toes Skin Antisepsis

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Terminated Cross-contamination Sage Products Inc D-0411-2018

Recalls by year