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

1,293 recalls, newest first

Class III · Low risk

Seconal Sodium

Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

Terminated Labeling / mix-up Valeant Pharmaceuticals North America LLC D-1059-2016
Class III · Low risk

Irbesartan and Hydrochlorothiazide Tablets

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

Terminated Labeling / mix-up Prinston Pharmaceutical Inc NDC 43547-331-09 D-1049-2016
Class III · Low risk

Doxycycline

Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.

Terminated Labeling / mix-up Galderma Laboratories, L.P. D-1031-2016
Class II · Moderate risk

Potassium CHLORide added to 5% Dextrose Injection

Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.

Terminated Labeling / mix-up Pharmedium Services, LLC NDC 61553-836-11 D-0976-2016
Class III · Low risk

Hectorol (doxercalciferol injection)

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

Terminated Labeling / mix-up Genzyme Corporation / Genzyme Biosurgery NDC 58468-0126-1 D-1029-2016
Class III · Low risk

SKY Aspirin Chewable Tablets

Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.

Terminated Labeling / mix-up Mckesson Packaging Services NDC 63739-434-01 D-0834-2016
Class III · Low risk

Fenofibrate Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-835-32 D-0823-2016
Class III · Low risk

Fenofibrate Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-835-32 D-0822-2016
Class I · High risk

PHENYLephrine 1 mg/10 mL

Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.

Terminated Labeling / mix-up QuVa Pharma, Inc. D-1066-2016
Class I · High risk

Cap-Biotin 100 Mg

Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine

Terminated Labeling / mix-up Reliable Rexall-A Compounding Pharmacy D-1068-2016
Class III · Low risk

Venlafaxine 75 mg Tablet

Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

Terminated Labeling / mix-up Bryant Ranch Prepack Inc. NDC 63629-3324-6 D-0837-2016
Class III · Low risk

Fenofibrate Capsules

Labeling: Incorrect or Missing Lot and/or Exp. Date

Terminated Labeling / mix-up Impax Laboratories, Inc. NDC 0115-0533-02 D-0821-2016
Class III · Low risk

Fenofibrate Capsules

Labeling: Incorrect or Missing Lot and/or Exp. Date

Terminated Labeling / mix-up Impax Laboratories, Inc. NDC 0115-0522-02 D-0820-2016
Class III · Low risk

Minocycline Hydrochloride Capsules USP

Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.

Terminated Labeling / mix-up Apace KY LLC NDC 50268-569-11 D-0811-2016
Class III · Low risk

Triamcinolone Diacetate Injectable Suspension

Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.

Terminated Labeling / mix-up Isomeric Pharmacy Solution, LLC D-0728-2016
Class II · Moderate risk

Nystatin

Labeling: label error on declared strength.

Terminated Labeling / mix-up Perrigo Company PLC NDC 0574-0404-15 D-0652-2016
Class II · Moderate risk

Nystatin

Labeling: label error on declared strength.

Terminated Labeling / mix-up Perrigo Company PLC NDC 0574-0405-05 D-0651-2016

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