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
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
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
Maximum Strength Lidocaine Cold & Hot Patch
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
Mencaine (lidocaine 4.5%, menthol 5%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
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
Class II · Moderate risk
Aloprim (allopurinol sodium)
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Class III · Low risk
Memantine Hydrochloride Extended-Release Capsules
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class III · Low risk
Esomeprazole Magnesium Delayed Release Capsules USP
Discoloration: product contains brown pellets
Class III · Low risk
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac)
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Class II · Moderate risk
Infuvite PEDiatric Pharmacy
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins