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

14 recalls · Class I, 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

Advil Liqui Gels

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0183-2023
Class I · High risk

Advil Liqui Gels

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0182-2023
Class I · High risk

Advil (ibuprofen)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0181-2023
Class I · High risk

Iohexol (300 mg Iodine/mL)

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Terminated Labeling / mix-up BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy D-0086-2023
Class I · High risk

Atenolol Tablets

Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets

Terminated Labeling / mix-up Golden State Medical Supply Inc. NDC 60429-027-10 D-0019-2023
Class I · High risk

Insulin Glargine

Labeling: Missing label: Label missing from some prefilled pens.

Terminated Labeling / mix-up Mylan Pharmaceuticals Inc NDC 49502-394-71 D-1292-2022
Class I · High risk

Morphine Sulfate extended-Release Tablets

Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Terminated Labeling / mix-up Bryant Ranch Prepack, Inc. NDC 63629-1089-01 D-1188-2022
Class I · High risk

Morphine Sulfate extended-Release Tablets

Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Terminated Labeling / mix-up Bryant Ranch Prepack, Inc. D-1187-2022
Class I · High risk

Insulin Glargine

Labeling: Missing label on the vial

Terminated Labeling / mix-up Mylan Pharmaceuticals Inc NDC 49502-393-80 D-0845-2022
Class I · High risk

Meclizine Hydrochloride Tablets USP

Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride

Terminated Labeling / mix-up Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-122-06 D-0767-2022
Class I · High risk

Morphine Sulfate PF 25 mg/25mL

Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A

Terminated Labeling / mix-up STAQ Pharma, Inc. D-0634-2022
Class I · High risk

HYDROmorphone HCl PF 10 mg/50 mL

Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A

Terminated Labeling / mix-up STAQ Pharma, Inc. D-0633-2022
Class I · High risk

Semglee (insulin glargine)

Labeling: Missing Label: label missing from some Semglee prefilled pens.

Terminated Labeling / mix-up Mylan Pharmaceuticals Inc NDC 49502-0196-71 D-0462-2022

Recalls by year