Class III · Low risk Terminated
Norpace CR
Reason Failed Dissolution Specification
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
NABUMETONE Tablets USP
Reason Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class III · Low risk Terminated
Prednisone 20 mg
Reason Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Magnesium Sulfate 7-Hydrate
Reason Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Class III · Low risk Terminated
Epsom Salt
Reason 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 Terminated
Meclizine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Duloxetine Delayed-release Capsules
Reason Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class III · Low risk Terminated
Ranitidine Syrup
Reason Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Class III · Low risk Terminated
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg
Reason Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class III · Low risk Terminated
HPMC Visoelastic
Reason Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
HPMC Visoelastic Topical
Reason Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
HPMC Visoelastic
Reason Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
Donnatal
Reason 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 Terminated
Fenofibric Acid Tablets 105 mg
Reason 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 Terminated
Fenofibric Acid Tablets
Reason 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 Terminated
Cetirizine HCl 10 mg Tablet
Reason Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Class III · Low risk Terminated
FUROSEMIDE Tablets USP
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk Terminated
FUROSEMIDE Tablets USP
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.