Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured ...
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 ...
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured...
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Di...
CGMP Deviations
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: ...
Failed Dissolution Specifications
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), R...
Defective container; inadequately sealed blister packaging.
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley ...
Lack of Assurance of Sterility
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescript...
Failed Dissolution Specifications
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5...
CGMP Deviations
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, P...
CGMP Deviations
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chlo...
CGMP Deviations
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Val...
Lack of Assurance of Sterility
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes...
CGMP Deviations
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; ...
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Sour...
Stability Data Does Not Support Expiry Date.
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: ...
Failed Dissolution Specifications
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works...
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 ...
CGMP Deviations
Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per bo...
CGMP Deviations
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes...
CGMP Deviations
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manu...
CGMP Deviations
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distrib...
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Val...
Lack of Assurance of Sterility
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactur...
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.