Burel Recalls Hyolev MB Urinary Antiseptic Tablets Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling 2,861 bottles of Hyolev MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
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 due to manufacturing deviations that may result in assay or content uniformity failures. No specific illnesses or injuries are reported, and the hazard is related to potential medication inconsistency rather than a high-risk pathogen or structural defect.
Plain-English summary
Burel Pharmaceuticals Inc is recalling 2,861 bottles of Hyolev MB URINARY ANTISEPTIC Tablets. The affected product is identified by Lot # 29001501 and an expiration date of 07/17. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations and deficiencies at the manufacturer.
These manufacturing issues may result in assay or content uniformity failures, meaning the medication may not contain the correct amount of active ingredients or may not be consistent throughout the bottle. The product is distributed nationwide and is available by prescription only.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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…
- Manufacturer
- Burel Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 2,861
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 (2)
- LOT # 29001501
- EXP 07/17
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
Same manufacturer · Burel Pharmaceuticals Inc
See all →- ModerateBurel Pharmaceuticals Recalls AZUPHEN MB Urinary Antiseptic Capsules
FDA (Drugs) · 2016-12-07
- ModerateBurel Pharmaceuticals Recalls Indiomin MB Capsules Due to Manufacturing Deficiencies
FDA (Drugs) · 2016-12-07
- Moderate
- ModerateBurel Pharmaceuticals Recalls Uramit MB Urinary Antiseptic Capsules
FDA (Drugs) · 2016-12-07
- ModerateBurel Pharmaceuticals Recalls UROLET MB Tablets Due to Manufacturing Deficiencies
FDA (Drugs) · 2016-12-07
Same hazard · manufacturing deficiency
See all →- ModerateCura Hongos clotrimazole cream recalled over manufacturing practice deviations
FDA (Drugs) · 2026-06-24
- ModerateMed Pride bacitracin zinc ointment recalled over manufacturing practice deviations
FDA (Drugs) · 2026-06-24
- ModerateLucky Super Soft athlete's foot cream recalled over manufacturing deviations
FDA (Drugs) · 2026-06-24
- ModerateMed Pride hydrocortisone cream 1oz tubes recalled over manufacturing deviations
FDA (Drugs) · 2026-06-24
- ModerateLil Drug Store triple antibiotic ointment recalled over manufacturing deviations
FDA (Drugs) · 2026-06-24
Similar recalls
- ModerateVilvet Pharmaceuticals Recalls VILEVEV MB Urinary Antiseptic Due to cGMP Deviations
FDA (Drugs) · 2020-08-12
- ModerateCystex Tablet Recall Due to CGMP Manufacturing Deviations
FDA (Drugs) · 2022-02-16
- LowMylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures
FDA (Drugs) · 2015-04-15
- SevereVirtus Recalls Hyoscyamine Sulfate Tablets Due to Potency Failures
FDA (Drugs) · 2016-12-28
- ModerateVilvet Pharmaceuticals Recalls VILAMIT MB Due to cGMP Deviations
FDA (Drugs) · 2020-08-12
- ModerateMylan Recalls Fexofenadine Tablets Due to Elevated Impurities
FDA (Drugs) · 2019-02-06