Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hyolev MB URINARY ANTISEPTIC Tablets Recalled by Burel Pharmaceuticals Inc Due to CGMP Deviations; deficiencies at the manufacturer may result...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Burel Pharmaceuticals Inc directly.
Affected Products
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
Quantity: 2861 bottles
Why Was This Recalled?
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Burel Pharmaceuticals Inc
Burel Pharmaceuticals Inc has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report