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Breckenridge Pharmaceutical, Inc.FDAMed source confidence · 80%Jun 23, 2026, 12:17 AM UTC · 15d ago

Breckenridge Pharmaceutical, Inc. — FDA Class II (D-0583-2026)

Case File

Breckenridge Pharmaceutical, Inc. is recalling 359,676 bottles of a human prescription drug due to contamination with N-nitrosodimethylamine (NDMA). This recall is classified as a CGMP deviation. The affected products are identified by NDC numbers 51991-746, 51991-747, 51991-748, and 51991-750.

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Key Points
  • Breckenridge Pharmaceutical is recalling 359,676 bottles of a human prescription drug.
  • The recall is due to contamination with N-nitrosodimethylamine (NDMA).
  • Affected products have NDC numbers 51991-746, 51991-747, 51991-748, and 51991-750.
  • Patients should check their medicine cabinets and stop using these drugs.
Why This Matters

Patients using the recalled drugs should stop using them and consult their healthcare provider. The recall affects 359,676 bottles, which could pose health risks due to contamination.

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