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

65 recalls, newest first

Class III · Low risk

Calendula Cream

Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.

Terminated Labeling / mix-up Boiron Inc. D-0803-2018
Class III · Low risk

Indomethacin Capsules USP

Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.

Terminated Labeling / mix-up Glenmark Pharmaceuticals Inc., USA NDC 68462-302-01 D-0606-2018
Class II · Moderate risk

Fluconazole Injection

Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.

Terminated Labeling / mix-up Renaissance Lakewood, LLC NDC 36000-002-10 D-0696-2018
Class III · Low risk

Klonopin (clonazepam)

Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.

Terminated Labeling / mix-up Genentech, Inc. NDC 0004-0068-01 D-0416-2018
Class III · Low risk

Oxycodone Hydrochloride Tablets

Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

Terminated Labeling / mix-up Ascent Pharmaceuticals, Inc. NDC 31722-917-01 D-0248-2018
Class I · High risk

Senna Laxative

Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.

Terminated Labeling / mix-up Magno Humphries Laboratories, Inc D-0342-2018
Class I · High risk

Clopidogrel Tablets

LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.

Terminated Labeling / mix-up International Laboratories, LLC NDC 54458-888-16 D-0472-2018

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