Burel Pharmaceuticals Azuphen MB Urinary Antiseptic Recall

Why it was recalled

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Product description

AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10

Lot numbers, UPCs & expiration codes

LOT # 29421501, EXP 10/17

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0159-2017
Classification: Class II
Status: Terminated
Recall initiated: Oct 24, 2016
FDA report date: Dec 7, 2016
Quantity: 604 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Burel Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0159-2017, exactly as published.

Show all FDA fields

City: Richland
State: MS
Status: Terminated
Country: United States
Event ID: 75566
Address: 199 Interstate Dr Ste N
Code information: LOT # 29421501, EXP 10/17
Postal code: 39218-9433
Report date: Dec 7, 2016
Product type: Drugs
Recall number: D-0159-2017
Classification: Class II
Recalling firm: Burel Pharmaceuticals Inc
Product quantity: 604 bottles
Termination date: Aug 14, 2017
Reason for recall: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Voluntary / mandated: Voluntary: Firm initiated
Product description: AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10
Distribution pattern: Nationwide
Recall initiation date: Oct 24, 2016
Initial firm notification: E-Mail
Center classification date: Nov 29, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0159-2017, published Dec 7, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Burel Pharmaceuticals AZUPHEN MB URINARY ANTISEPTIC Capsules Recall

Summary