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 I · High risk

Tranexamic Acid Injection

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Terminated Labeling / mix-up Mylan Institutional LLC NDC 67457-197-00 D-1576-2020
Class I · High risk

Amiodarone Hydrochloride Injection

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Terminated Labeling / mix-up Mylan Institutional LLC NDC 67457-153-99 D-1575-2020
Class II · Moderate risk

Prednisone Tablets

Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg

Terminated Labeling / mix-up Lannett Company, Inc. NDC 0527-2931-37 D-1508-2020
Class II · Moderate risk

Just Hand Sanitizer

Labeling Not Elsewhere Classified: Product labeled to contain methanol

Terminated Labeling / mix-up Open Book Extracts NDC 78065-2020-2 D-1564-2020
Class III · Low risk

Red Cross Oral Pain

Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.

Terminated Labeling / mix-up The Mentholatum Company NDC 10742-8902-1 D-1541-2020
Class II · Moderate risk

Lidocaine Patch 5%

Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.

Terminated Labeling / mix-up Teva Pharmaceuticals USA NDC 0591-3525-30 D-1492-2020
Class III · Low risk

Fosaprepitant for Injection

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

Terminated Labeling / mix-up Fresenius Kabi USA, LLC NDC 63323-972-10 D-1391-2020
Class III · Low risk

Nabumetone Tablets

Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.

Terminated Labeling / mix-up American Health Packaging D-1372-2020
Class II · Moderate risk

Aripiprazole Tablets

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.

Terminated Labeling / mix-up Alembic Pharmaceuticals Limited NDC 62332-097-30 D-1341-2020
Class II · Moderate risk

Gaviscon Liquid Antacid Extra Strength

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings NDC 0135-0095-41 D-1325-2020
Class II · Moderate risk

Lisinopril Tablets

Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.

Terminated Labeling / mix-up Lupin Pharmaceuticals Inc. NDC 68180-513-03 D-1290-2020
Class II · Moderate risk

Lisinopril Tablets USP

Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.

Terminated Labeling / mix-up Lupin Pharmaceuticals Inc. NDC 68180-0981-03 D-1250-2020

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