Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2012

Every FDA drug recall initiated in 2012, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

534 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2012 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
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
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 III · Low risk

Hydroxyzine Hydrochloride Oral Solution

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Terminated Impurity / degradation Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals NDC 0603-1310-58 D-1417-2012

Recalls by year