Class II · Moderate risk Terminated
Lisinopril Tablets
Reason Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk Terminated
Duavee
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/ Degradation Specifications
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/ Degradation Specifications
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason 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 Terminated
NP Thyroid 90
Reason Superpotent Drug.
Class I · High risk Terminated
NP Thyroid 60
Reason Superpotent Drug.
Class I · High risk Terminated
NP Thyroid 30
Reason Superpotent Drug.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason 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 Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class III · Low risk Terminated
Zilretta
Reason Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class II · Moderate risk Terminated
EcoLips Sport Lip Balm
Reason 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 Terminated
Estriol USP Micronized 5 G
Reason Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class II · Moderate risk Terminated
Doxycycline Hyclate tablets USP
Reason Failed dissolution specifications
Class III · Low risk Terminated
Gabapentin Tablets USP
Reason Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class III · Low risk Terminated
Ethacrynic Acid Tablets USP
Reason Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets USP
Reason 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 Terminated
Sterile Curcumin 50mg/mL
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin