DrugFeb 5, 2025
Astagraf XL recall — FDA D-0210-2025
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class IFDA: OngoingAstellas Pharma US Inc.
Recall history in this database
Classification mix: Class II: 2, Class I: 1.
DrugOct 15, 2014
Astellas Pharma US Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle recall — FDA D-0008-2015
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Class IIFDA: TerminatedAstellas Pharma US Inc.
DrugJul 31, 2013
Astellas Pharma US AmBisome (amphotericin B) liposome for injection, 50mg vial, single use recall — FDA D-820-2013
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine…
Class IIFDA: TerminatedAstellas Pharma US Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Astellas Pharma US Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.