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

1,134 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2017 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Povidone Iodine

Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.

Terminated Labeling / mix-up Degasa Sa De Cv NDC 68345-350-09 D-1129-2017
Class II · Moderate risk

Vitamin A&D Ointment

Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.

Terminated Labeling / mix-up Medline Industries INC D-1138-2017
Class III · Low risk

Phentermine HCL Capsules

Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

Terminated Impurity / degradation KVK-Tech, Inc. NDC 10702-026-01 D-1083-2017
Class I · High risk

Lorazepam Oral Concentrate

Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.

Terminated Packaging defect Amneal Pharmaceuticals of New York, LLC NDC 65162-687-84 D-0120-2018
Class II · Moderate risk

Rugby Aller-chlor

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Terminated Microbial contamination The Harvard Drug Group D-1122-2017
Class II · Moderate risk

Rugby Diocto Syrup

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Terminated Microbial contamination The Harvard Drug Group D-1120-2017
Class II · Moderate risk

Rugby Diocto Liquid

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Terminated Microbial contamination The Harvard Drug Group D-1119-2017
Class I · High risk

Natural Herbal Coffee Ampt

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.

Terminated Chemical / undeclared The Ampt Life, LLC D-0126-2018
Class II · Moderate risk

Famotidine USP 20 mg

Failed Tablet/Capsule Specification: out of specification for tablet weight.

Terminated Failed specification PD-Rx Pharmaceuticals, Inc. NDC 55289-765-30 D-1057-2017
Class II · Moderate risk

Famotidine Tablets USP

Failed Tablet/Capsule Specification; out of specification for tablet weight

Terminated Failed specification Teva Pharmaceuticals USA NDC 0172-5728-60 D-1056-2017
Class II · Moderate risk

Entecavir Tablets 0.5 mg

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

Terminated Impurity / degradation Hetero USA Inc NDC 31722-833-30 D-1095-2017

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