Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
FDA Drug Recalls
97 recalls, newest first
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened..
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened..
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened..
Class III · Low risk
Camila 0.35 mg Tablets
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Camila (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Errin (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Balziva (norethindrone and ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Junel
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Lessina (Levonorgestrel and ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Camrese (Levonorgestrel/Ethinyl Estradiol Tablets)
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class III · Low risk
Seasonale (Levonorgestrel/Ethinyl Estradiol Tablets)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class I · High risk
Night Bullet Capsules
Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.
Class III · Low risk
Femhrt (norethindrone acetate and ethinyl estradiol)
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Jevantique
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Femhrt (norethindrone acetate and ethinyl estradiol)
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Montelukast Sodium Tablets
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Class I · High risk
MAXILOSS Weight Advanced
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Class I · High risk
Reumofan Plus
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.