Severity
Moderate
ModerateClass IITerminated
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
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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 FDA Drug action (record #D-0155-2017) was formally reported on December 7, 2016, with the manufacturer initiating the action on October 24, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Burel Pharmaceuticals Inc is listed as the recalling firm, operating out of Richland, MS. Federal records list the affected scope as 2861 bottles.
The documented reason for this recall is: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Distribution data in the federal record shows the product reached: Nationwide. Distribution scope 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, 5 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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
2861 bottles
Related Recalls
6
5 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Burel Pharmaceuticals Inc. Units affected: 2861 bottles.
Why was this product recalled? ▼
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 7, 2016. Severity: Moderate. Recall number: D-0155-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0155-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 7, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.