Class I · High risk
VITRAKVI (larotractenib)
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
FDA Drug Recalls
19 recalls · Class I, newest first
Class I · High risk
Lubricating Tears Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
Phenytoin Oral Suspension
Failed Content Uniformity Specifications
Class I · High risk
Sucralfate Oral Suspension
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class I · High risk
2% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
4.2% Sodium Bicarbonate Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
ION*Sinus Spray
Microbial contamination of Non-Sterile Products
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I · High risk
WEFUN Capsules 825 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class I · High risk
Tydemy
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Class I · High risk
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Class I · High risk
G-Supress DX
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class I · High risk
SOFT HANDS Alcohol Antiseptic 80%
Chemical Contamination: FDA testing found Presence of methanol
Class I · High risk
Alcohol Antiseptic 80%
Chemical Contamination: FDA testing found Presence of methanol
Class I · High risk
PrimeZEN Black 6000 capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.