Class I · High risk Terminated
Ruzurgi
Reason Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
AMINOSYN II 15% An Amino Acid Injection
Reason Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class I · High risk Terminated
Avicel RC-591 NF
Reason Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Class I · High risk Terminated
Firvanq
Reason Product Mix-up: Incorrect diluent component included in the kit.
Class I · High risk Completed
X Rated Honey for Men
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class I · High risk Terminated
Hydro Pinapple Burn Max Health Thach Dua
Reason Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Class I · High risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection
Reason Non-Sterility: firm's third party lab confirmed microbial contamination.
Class I · High risk Ongoing
Lidocaine Hydrochloride Topical Solution
Reason Superpotent Drug
Class I · High risk Terminated
365 SKINNY High Intensity Capsules
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Class I · High risk Ongoing
ALPHA MALE+ Male Enhancer
Reason Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class I · High risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason Chemical Contamination: presence of benzene
Class I · High risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason Chemical Contamination: presence of benzene
Class I · High risk Ongoing
Vy&Tea
Reason Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
Class I · High risk Terminated
Atovaquone Oral Suspension
Reason Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class I · High risk Ongoing
Limar Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk Terminated
Prairie Wolf Distillery Alcohol Antiseptic 80%
Reason Hand sanitizer packaged in bottles that resemble beverage containers.
Class I · High risk Terminated
Topotecan Injection 4 mg/4mL
Reason Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class I · High risk Terminated
maXXzen Platinum 12000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk Terminated
PremierZEN Platinum 8000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk Terminated
PremierZEN Gold 7000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk Terminated
C-Progesterone Oil 100 Mg/Ml
Reason Non-Sterility
Class I · High risk Terminated
Poseidon Platinum 3500 capsule
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk Terminated
DiBAR LABS Hand Sanitizer
Reason Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.