Class I · High risk Terminated
Artri King Reforzado con Ortiga y Omega 3 tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Ortiga mas Ajo Rey Reforzado con Omega 3
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk Terminated
Artri Ajo King Reforzado con Ortiga y Omega 3 tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk Completed
Artri King Reforzado con Ortiga Omega 3 Tablets
Reason Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Class I · High risk Terminated
Tegsedi
Reason Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class I · High risk Terminated
Anagrelide Capsules USP
Reason Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Class I · High risk Terminated
Tacrolimus
Reason Subpotent drug
Class I · High risk Terminated
Tacrolimus
Reason Subpotent drug
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label on the vial
Class I · High risk Completed
Humalog KwikPen
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
The Mandalorian Hand Sanitizer
Reason Chemical Contamination; FDA analysis found product to contain benzene
Class I · High risk Terminated
Mickey Mouse Hand Sanitizer
Reason Chemical Contamination; FDA analysis found product to contain methanol
Class I · High risk Terminated
Pink Pussycat SENSUAL ENHANCEMENT capsule
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
IDArubicin Hydrochloride Injection USP 5gm/5mL
Reason Presence of Particulate Matter: Product was found to contain silica and iron oxide
Class I · High risk Completed
Magnesium Hydroxide 1200mg
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Completed
Milk of Magnesia USP
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class I · High risk Terminated
Meclizine Hydrochloride Tablets USP
Reason Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class I · High risk Completed
SyrSpend SF Suspending Base
Reason Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I · High risk Terminated
Sodium Acetate Injection
Reason Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class I · High risk Terminated
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%
Reason Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Class I · High risk Ongoing
Sure Regular Antiperspirant Deodorant Aerosol
Reason Chemical contamination: Presence of benzene
Class I · High risk Ongoing
Sure Unscented Anti-perspirant Deodorant Aerosol
Reason Chemical contamination: Presence of benzene