Class III · Low risk Terminated
ClomiPRAMINE Hydrochloride Capsules
Reason Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Ongoing
Timolol Maleate Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Class III · Low risk Terminated
Nighttime Sleep-Aid
Reason Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class III · Low risk Terminated
Acetaminophen 500 mg tablet
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class III · Low risk Terminated
Acetaminophen 325 mg tablets
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class III · Low risk Terminated
Zynrelef
Reason Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class III · Low risk Terminated
Azacitidine for Injection
Reason Subpotent Drug
Class III · Low risk Terminated
Azacitidine for Injection 100mg/vial Lyophilized Powder
Reason Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Labeling: Label Error on Declared Strength
Class III · Low risk Ongoing
Tacrolimus Ointment
Reason Defective Container: Tube split from side seam
Class III · Low risk Completed
Crest 3D White Fluoride Anticavity Toothpaste
Reason Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Class III · Low risk Terminated
Juice Beauty
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Juice Beauty
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Aspirin and Extended-Release Dipyridamole Capsules
Reason Failed Tablet/Capsule Specification : Capsule breakage
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk Terminated
Mometasone Furoate
Reason Defective Container
Class III · Low risk Terminated
Alprostadil Injection USP 500 mcg/mL
Reason Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class III · Low risk Terminated
Tivicay
Reason Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Sirolimus Oral Solution
Reason Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk Terminated
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.