Astellas Pharma US recalls

Astellas Pharma US has 5 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 5 Feb 2025. 2 are still ongoing. The most frequent reason is packaging defects.

Total recalls5since 2013

Last 12 months0reported

Class I240% of total

Ongoing2latest 5 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 2 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 40%Class II 3 60%Class III 0 0%

Why astellas pharma us is recalled

Product types

Injectable & IV Drugs240%

Brands

By year

2025240%
2018120%
2014120%
2013120%

Ongoing astellas pharma us recalls

2 active

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Drug	CLASS I	Astagraf XL (tacrolimus extended-release capsules) 5 mg recalledAstagraf Xl	Astellas Pharma US	Packaging Defects	Nationwide
5 Feb 2025Drug	CLASS I	Prograf (tacrolimus) capsules, USP, 5 mg recalled by Astellas Pharma USPrograf	Astellas Pharma US	Packaging Defects	Nationwide

All astellas pharma us recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Drug	CLASS I	Astagraf XL (tacrolimus extended-release capsules) 5 mg recalledAstagraf Xl	Astellas Pharma US	Packaging Defects	Nationwide
5 Feb 2025Drug	CLASS I	Prograf (tacrolimus) capsules, USP, 5 mg recalled by Astellas Pharma USPrograf	Astellas Pharma US	Packaging Defects	Nationwide
14 Feb 2018Drug	CLASS II	Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial recalledMycamine	Astellas Pharma US	Other	Nationwide
15 Oct 2014Drug	CLASS II	Tarceva (erlotinib) Tablets, 150 mg recalled by Astellas Pharma US	Astellas Pharma US	Potency & Assay	Nationwide
31 Jul 2013Drug	CLASS II	AmBisome (amphotericin B) liposome for injection, 50mg vial recalled	Astellas Pharma US	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.