Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

11,818 recalls · Class II, 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

Merrem I.V.

Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

Terminated Failed specification AstraZeneca Pharmaceuticals LP D-840-2013
Class II · Moderate risk

AmBisome (amphotericin B)

Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.

Terminated Microbial contamination Gilead Sciences, Inc. NDC 0469-3051-30 D-821-2013
Class II · Moderate risk

AmBisome (amphotericin B)

Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.

Terminated Microbial contamination Astellas Pharma US Inc D-820-2013
Class II · Moderate risk

Theraflu Cold and Flu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-763-2014
Class II · Moderate risk

Theraflu Exte

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-762-2014
Class II · Moderate risk

NeoCitran

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health D-758-2014
Class II · Moderate risk

Theraflu

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Terminated Particulate / foreign matter Novartis Consumer Health NDC 0067-6319-06 D-751-2014
Class II · Moderate risk

Belladonna Alkaloids/PB

Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

Terminated Particulate / foreign matter Physicians Total Care, Inc. NDC 54868-0031-04 D-826-2013

Recalls by year