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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-0544-2026)

Case File

Zydus Pharmaceuticals (USA) Inc is recalling 23,880 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 23,880 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 these products.
  • Contamination with N-Nitros poses potential health risks.
Why This Matters

Consumers with the recalled products should stop using them immediately due to contamination risks. The recall affects 23,880 bottles.

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