Class I · High risk
Umovy Acido Hialuronico
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
FDA Drug Recalls
56 recalls · Class I, newest first
Class I · High risk
Unavy Acido Hialuronico
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Class I · High risk
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Class I · High risk
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Chemical Contamination; presence of benzene.
Class I · High risk
Americaine
Chemical Contamination: presence of benzene
Class I · High risk
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Chemical Contamination; presence of benzene.
Class I · High risk
Vigabatrin for Oral Solution
Defective Container: powder may leak out of the pouch
Class I · High risk
Brexafemme
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Class I · High risk
Artri King Reforzado con Ortiga Omega 3 Tablets
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
Humalog KwikPen
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk
Magnesium Hydroxide 1200mg
Microbial Contamination of Non-Sterile Products
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
Class I · High risk
SyrSpend SF Suspending Base
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I · High risk
AmericanScreening HAND SANITIZER
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk
Enoxaparin Sodium Injection
Temperature Abuse; temperature excursion during shipping
Class I · High risk
Methocarbamol 500mg Tablet
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class I · High risk
X Rated Honey for Men
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class I · High risk
Paroex (chlorhexidine gluconate)
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Class I · High risk
Herbzeedy
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
Goodness Gurus
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
Goodness Gurus
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
BC Hemp Co.
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
BC Hemp Co.
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
Tasty Drops
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
Tasty Drops
Chemical contamination: product contains elevated levels of undeclared lead.