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

Oxycodone HCl Oral Concentrate

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 00527-1426-36 D-1447-2014
Class I · High risk

Taztia XT (Diltiazem HCl)

Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 62037-0696-90 D-1446-2014
Class II · Moderate risk

Arthrotec 75

Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.

Terminated Failed specification Physicians Total Care, Inc. NDC 54868-4165-1 D-1379-2012
Class II · Moderate risk

Murocel (methylcellulose)

Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.

Terminated Sterility / contamination Bausch & Lomb, Inc. NDC 24208-280-15 D-1370-2012
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 54092-552-01 D-1375-2012
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 54092-553-01 D-1374-2012
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 54092-555-01 D-1373-2012
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 54092-554-30 D-1372-2012
Class III · Low risk

Azelastine HCl Nasal Solution

CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

Terminated cGMP deviation Apotex Corp. NDC 60505-0833-5 D-1667-2012
Class III · Low risk

Percocet 10/325 mg tablets

Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.

Terminated Particulate / foreign matter Physicians Total Care, Inc. NDC 54868-4710-0 D-301-2013
Class II · Moderate risk

Metronidazole Tablets

Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.

Terminated Failed specification Physicians Total Care, Inc. NDC 54868-0158-3 D-547-2013
Class II · Moderate risk

Xactdose Phenytoin Oral Suspension

Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume

Terminated Wrong potency / content VistaPharm, Inc. NDC 66689-035-50 D-1658-2012
Class II · Moderate risk

Methylprednisolone Tablets

Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life

Terminated Impurity / degradation Physicians Total Care, Inc. NDC 54868-2913-03 D-1391-2012
Class III · Low risk

Earth Force

Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).

Terminated Chemical / undeclared Abc Compounding Company Inc D-011-2013
Class III · Low risk

Plavix 75 mg

Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).

Terminated Chemical / undeclared Physicians Total Care, Inc. D-317-2013
Class III · Low risk

Metoclopramide Oral Solution

Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"

Terminated Labeling / mix-up VistaPharm, Inc. D-1669-2012

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