Burel Pharmaceuticals Recalls UROLET MB Tablets Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling UROLET MB Urinary Antiseptic tablets because manufacturing deficiencies may cause the product to fail potency or uniformity tests.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential potency or uniformity failures without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Burel Pharmaceuticals Inc is recalling UROLET MB Urinary Antiseptic, Antispasmodic Tablets. The recall involves 11,539 bottles of the prescription medication, which are distributed nationwide. The affected products include 30-count bottles (NDC 35573-302-30) and 100-count bottles (NDC 35573-302-10). Specific lot numbers and expiration dates are listed in the structured product information.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and deficiencies at the manufacturer. These issues may result in the tablets failing assay or content uniformity tests, meaning the medication may not contain the correct amount of active ingredients or may not be consistent in potency.
Consumers who have purchased these specific lots of UROLET MB tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC…
- Manufacturer
- Burel Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 11,539
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- (a) LOT # 28981501
- EXP 8/17
- NDC 35573-302-30
- (b) LOT # 28981501
- LOT # 28981601
- EXP 4/18
- NDC 35573-302-10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Burel Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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