FDA Drug recall D-0155-2017
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methyle…
- FDA Drug
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methyle… by Burel Pharmaceuticals, citing CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0155-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-24 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Burel Pharmaceuticals |
| Distribution | US |
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 PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Identifiers
| code_info | LOT # 29001501, EXP 07/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Burel Pharmaceuticals
- Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Meth…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene B…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals - URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
All Burel Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0155-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.