Astagraf XL recall — FDA D-0210-2025
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
754 detailed records are currently available in this category.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Failed Stability Specifications
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
CGMP Deviations
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical…
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
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