Manufacturer
5 recalls in our database name Astellas Pharma US Inc. as the manufacturing or recalling firm.
Of the 5 recalls from Astellas Pharma US Inc. we have scored against our rubric, 1 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (40%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.
Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.
Astellas Pharma US Inc is recalling 63,600 vials of Mycamine (micafungin sodium) for Injection due to a label error on the declared strength.
Astellas Pharma US Inc is recalling 9,236 bottles of Tarceva (erlotinib) 150 mg tablets because they failed routine stability testing for dissolution.
Astellas Pharma US is voluntarily recalling specific lots of AmBisome (amphotericin B) liposome for injection because a routine simulation detected bacterial contamination.