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Zydus Pharmaceuticals (USA) IncFDAMed source confidence · 80%Jun 22, 2026, 10:00 AM UTC · 16d ago

Zydus Pharmaceuticals (USA) Inc — FDA Class II (D-0545-2026)

Case File

Zydus Pharmaceuticals (USA) Inc is recalling 10,992 bottles of a human prescription drug due to CGMP deviations related to N-Nitros contamination. This recall is classified as a Class II recall. The affected products are distributed in the United States.

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Key Points
  • Zydus Pharmaceuticals is recalling 10,992 bottles of a human prescription drug.
  • The recall is due to contamination with N-Nitros.
  • This is classified as a Class II recall.
  • Consumers should check their medicine cabinets for the affected products.
  • Recalls like this can lead to increased regulatory scrutiny.
Why This Matters

Consumers with the recalled product should stop using it immediately due to potential health risks from contamination. The recall affects 10,992 bottles.

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SIGNA Wire provides informational summaries of official government filings. Not investment advice.