Class I · High risk
AMINOSYN II 15% An Amino Acid Injection
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
Avicel RC-591 NF
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Class I · High risk
Firvanq (vancomycin hydrochloride for oral solution)
Product Mix-up: Incorrect diluent component included in the kit.
Class I · High risk
Hydro Pinapple Burn Max Health Thach Dua
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Class I · High risk
Sodium Bicarbonate in 5% Dextrose Injection
Non-Sterility: firm's third party lab confirmed microbial contamination.
Class I · High risk
365 SKINNY High Intensity Capsules
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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.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
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class I · High risk
Prairie Wolf Distillery Alcohol Antiseptic 80%
Hand sanitizer packaged in bottles that resemble beverage containers.
Class I · High risk
Topotecan Injection 4 mg/4mL
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
maXXzen Platinum 12000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
PremierZEN Platinum 8000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
PremierZEN Gold 7000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
C-Progesterone Oil 100 Mg/Ml
Non-Sterility
Class I · High risk
Poseidon Platinum 3500 capsule
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
DiBAR LABS Hand Sanitizer
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Class I · High risk
1% Lidocaine HCl Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I · High risk
0.5% Bupivacaine Hydrochloride Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I · High risk
NP Thyroid 120 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 90 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 60 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 30 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 15 Thyroid Tablets
Subpotent Drug
Class I · High risk
Coconut Stand CoCo TKO Hand Sanitizer
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Tropical Daydream
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Watermelon Lemonade
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.