FDA Drug recall · Reported December 7, 2016
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
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Burel Pharmaceuticals Inc recalled Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyosc… - a moderate-severity action.
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyosc… was recalled by Burel Pharmaceuticals Inc in December 7, 2016. Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures. Check the official notice for the remedy. Verify recall #D-0155-2017 with the FDA Drug before acting.
The recall
Burel Pharmaceuticals Inc issued this moderate-severity FDA Drug recall-CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures.
- Moderate
- severity level
- Class II
- classification
- December 7, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0155-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
Reason for recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0155-2017 |
| Date reported | December 7, 2016 |
| Date initiated | October 24, 2016 |
| Recalling firm | Burel Pharmaceuticals Inc |
| Firm location | Richland, MS |
| Affected scope | 2861 bottles |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0155-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026