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

18,003 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

Synthroid (levothyroxine sodium)

Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.

Terminated Packaging defect Abbott Laboratories D-1696-2012
Class II · Moderate risk

Synthroid (levothyroxine sodium)

Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.

Terminated Packaging defect Abbott Laboratories D-1695-2012
Class II · Moderate risk

Synthroid (levothyroxine sodium)

Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.

Terminated Packaging defect Abbott Laboratories D-1694-2012
Class III · Low risk

Fougera Ketoconazole Cream 2%

Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product

Terminated Impurity / degradation Fougera Pharmaceuticals Inc. NDC 0168-0099-15 D-241-2013
Class II · Moderate risk

Walgreens ASPIRIN FREE TENSION HEADACHE

Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.

Terminated Chemical / undeclared LNK International, Inc. NDC 0363-0428-12 D-0319-2015
Class I · High risk

X-ROCK 3 Day Pill For Men

Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

Terminated Chemical / undeclared Coral Rock Man, Inc. D-038-2013
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1655-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1654-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1653-2012
Class III · Low risk

Major brand Infants' Mapap

Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014

Terminated Stability / shelf life Axcentria Pharmaceuticals LLC NDC 0904-5255-30 D-1441-2012
Class II · Moderate risk

Levothroid

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa NDC 0456-1328-01 D-085-2013
Class II · Moderate risk

Thyro-Tab 0.300 mg.

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa D-084-2013
Class II · Moderate risk

Levothroid

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa NDC 0456-1331-01 D-083-2013
Class II · Moderate risk

Thyro-Tab 0.137 mg.

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa D-082-2013
Class II · Moderate risk

Levothroid

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa NDC 0456-1324-01 D-081-2013
Class II · Moderate risk

Thyro-Tab 0.125 mg.

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa D-080-2013
Class II · Moderate risk

Levothroid

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa NDC 0456-1330-01 D-079-2013
Class II · Moderate risk

Thyro-Tab 0.112 mg.

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa D-078-2013
Class II · Moderate risk

Levothroid

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa NDC 0456-1329-01 D-077-2013
Class II · Moderate risk

Thyro-Tab 0.088 mg.

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa D-076-2013
Class II · Moderate risk

Levothroid

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa NDC 0456-1321-01 D-075-2013
Class II · Moderate risk

Thyro-Tab 0.050 mg.

cGMP Deviations; does not meet in process specification requirements

Terminated cGMP deviation Lloyd Inc. of Iowa D-074-2013

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