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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.
•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.