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

79 recalls · Class I, newest first

Class I · High risk

Clonazepam Orally Disintegrating Tablets

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

Terminated Labeling / mix-up Endo Pharmaceuticals, Inc. NDC 49884-306-02 D-0622-2024
Class I · High risk

Acetaminophen Extra Strength Tablets

Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.

Terminated Labeling / mix-up A-S Medication Solutions LLC D-0631-2024
Class I · High risk

Digoxin Tablets

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Terminated Labeling / mix-up Marlex Pharmaceuticals, Inc. NDC 10135-0747-01 D-1169-2023
Class I · High risk

ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

Terminated Labeling / mix-up The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6269-08 D-0893-2023
Class I · High risk

G-Supress DX

Product mix-up: incorrect product was found inside the G-Supress DX product carton.

Terminated Labeling / mix-up Novis PR, LLC dba Kramer Novis NDC 52083-655-01 D-0868-2023
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-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
Class I · High risk

1% Lidocaine HCl Injection

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Terminated Labeling / mix-up Pfizer, INC NDC 0409-4279-16 D-0627-2021
Class I · High risk

0.5% Bupivacaine Hydrochloride Injection

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Terminated Labeling / mix-up Pfizer, INC NDC 0409-1162-19 D-0626-2021
Class I · High risk

heal the world

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

Terminated Labeling / mix-up Pnhc, LLC. D-0365-2021

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