Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phenazopyridine Hydrochloride 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
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Quantity: 17,788 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