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

14,806 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

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 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 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 I · High risk

Enteric Coated Aspirin

Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.

Terminated Labeling / mix-up Advance Pharmaceutical Inc NDC 0536-3086-41 D-919-2013
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

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