Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
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.
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.
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.
CGMP Deviations
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Lack of Assurance of Sterility
Defective Container: Carton is missing the tablet blister strip and tablet.
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.
Failed Moisture Limits: Product tested out-of-specification for moisture content.
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
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.
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets