Class III · Low risk
Lumizyme (alglucosidase alpha)
Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Quinapril Tablets USP 5 mg
Failed Impurities/Degradation Specifications; Impurity A
Class III · Low risk
Norpace CR
Failed Dissolution Specification
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
NABUMETONE Tablets USP
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class III · Low risk
Prednisone 20 mg
Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Magnesium Sulfate 7-Hydrate
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Class III · Low risk
Epsom Salt
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
Class III · Low risk
Meclizine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Duloxetine Delayed-release Capsules
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class III · Low risk
Ranitidine Syrup
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Class III · Low risk
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
HPMC Visoelastic Topical
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
Donnatal
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Class III · Low risk
Fenofibric Acid Tablets 105 mg
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class III · Low risk
Fenofibric Acid Tablets
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class III · Low risk
Cetirizine HCl 10 mg Tablet
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester