Class III · Low risk
Clonidine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
FDA Drug Recalls
832 recalls, newest first
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class I · High risk
NP Thyroid 90
Superpotent Drug.
Class I · High risk
NP Thyroid 60
Superpotent Drug.
Class I · High risk
NP Thyroid 30
Superpotent Drug.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class III · Low risk
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class II · Moderate risk
EcoLips Sport Lip Balm
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Class II · Moderate risk
Estriol USP Micronized 5 G
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class II · Moderate risk
Doxycycline Hyclate tablets USP
Failed dissolution specifications
Class III · Low risk
Gabapentin Tablets USP
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class III · Low risk
Ethacrynic Acid Tablets USP
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Class II · Moderate risk
Doxycycline Hyclate Tablets USP
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Class II · Moderate risk
Sterile Curcumin 50mg/mL
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Curcumin
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class I · High risk
LACTATED RINGER'S Injection
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Class III · Low risk
Potassium Acetate Injection
Short Fill