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

1,525 recalls · Class III, 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 III · Low risk

Cetirizine HCl Chewable Tablet

Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Terminated Impurity / degradation Sandoz, Inc NDC 66394-041-06 D-1115-2015
Class III · Low risk

Monistat 1 Simple Cure

Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.

Terminated Unapproved drug Medtech Products, Inc. NDC 63736-013-30 D-1077-2015
Class III · Low risk

Fexofenadine Hydrochloride Tablets

Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-547-20 D-1083-2015
Class III · Low risk

Promethazine Vc With Codeine Syrup

Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

Terminated Impurity / degradation Qualitest Pharmaceuticals NDC 0603-1588-54 D00432-2015
Class III · Low risk

Fluorescein Sodium Ophthalmic Strips USP

Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.

Terminated Wrong potency / content Nomax Inc NDC 17478-404-01 D-0963-2015
Class III · Low risk

Rose Bengal GloStrips

Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.

Terminated Wrong potency / content Nomax Inc NDC 51801-004-01 D-0962-2015
Class III · Low risk

Fluorescein Sodium Ophthalmic Strips USP

Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.

Terminated Wrong potency / content Nomax Inc NDC 51801-003-01 D-0961-2015
Class III · Low risk

Fexofenadine HCl Tablets

Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Terminated Impurity / degradation Mylan Pharmaceuticals Inc. NDC 0378-0781-91 D-0435-2015
Class III · Low risk

Air Compressed

Failed Impurities/Degradation Specification; out of specification results for carbon dioxide

Terminated Impurity / degradation Matheson, Inc. D-0423-2015

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