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ENDO USA, Inc.FDAMed source confidence · 80%Jun 22, 2026, 10:01 AM UTC · 16d ago
ENDO USA, Inc. — FDA Class II (D-0527-2026)
Case File
ENDO USA, Inc. is recalling 34,293 vials of a human prescription drug due to crystallization issues. This recall is classified as a safety issue and affects products administered intramuscularly and intravenously. The recall is part of the FDA's enforcement actions to ensure drug safety.
•ENDO USA, Inc. is recalling 34,293 vials of a prescription drug.
•The recall is due to crystallization issues.
•The product is administered intramuscularly and intravenously.
•Patients should check for affected vials to avoid health risks.
•Class I recalls indicate serious safety concerns.
Why This Matters
Patients who have received this drug should verify if they have the recalled vials. The recall affects 34,293 vials, which could pose serious health risks.