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

2,357 recalls · Class II, newest first

Class II · Moderate risk

Miss Slim

Marketed without ANDA/NDA approval

Ongoing Other His Enterprise INC D-0770-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Ongoing Nitrosamine impurity Pfizer Inc. NDC 0069-0469-56 D-0701-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Ongoing Nitrosamine impurity Pfizer Inc. NDC 0069-0471-03 D-0700-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Ongoing Nitrosamine impurity Pfizer Inc. NDC 0069-0468-56 D-0699-2021
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Ongoing Packaging defect Noven Pharmaceuticals Inc NDC 68968-5553-1 D-0394-2021
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Ongoing Packaging defect Noven Pharmaceuticals Inc NDC 68968-5552-1 D-0393-2021

Recalls by year