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

14,535 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

Custom Access Tray

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags

Terminated Sterility / contamination Custom Medical Specialties, Inc. D-1649-2012
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-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 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 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 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
Class II · Moderate risk

Naproxen Tablets USP

Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.

Terminated Labeling / mix-up Glenmark Generics Inc., USA NDC 68462-190-01 D-1701-2012
Class II · Moderate risk

Mercaptopurine Tablets

Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.

Terminated Dissolution failure Prometheus Laboratories Inc. NDC 49884-922-02 D-1659-2012

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