Class I · High risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Subpotent Drug: found to be below the specification for labeled assay.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
VenomX
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
StaphWash+Plus+ Skin Protectant
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
StingMed Insect bites Skin Protectant. Zinc acetate
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
Diabecline brand Topical Ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
TetraStem brand Topical Ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I · High risk
Andropharm M1 Alpha
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk
Andropharm Sten Z
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class II · Moderate risk
NasalCrom (cromolyn sodium)
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class I · High risk
EliquisTablets 5mg
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Class III · Low risk
Walgreens Daytime and Nighttime Cold & Flu
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Class II · Moderate risk
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Class III · Low risk
G & W Clobetasol Propionate Ointment 0.05%
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Class II · Moderate risk
Chlorhexidine Gluconate 0.12% Oral Rinse
CGMP Deviations
Class II · Moderate risk
Doxycycline Hyclate USP
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules USP
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Class II · Moderate risk
methylcobalamin 1mg/1mL
Lack of Assurance of Sterility
Class II · Moderate risk
Option 2
Defective Container: Carton is missing the tablet blister strip and tablet.
Class I · High risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Class III · Low risk
BuPROPion HCL Tablets
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Class II · Moderate risk
Methocarbamol
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Class I · High risk
CaverFlo Natural Herbal Coffee
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Class I · High risk
BRILINTA (ticagrelor)
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class III · Low risk
PONSTEL (Mefanamic Acid)
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing