CLASS II Drug recall · Reported 12 Aug 2020 · FDA Enforcement Report
Vilevev MB Urinary Antispetic (81.0 mg methenamine recalled
Vilvet Pharmaceuticals is recalling Vilevev MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic, distributed nationwide in the US. The recall was initiated on 24 Jul 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1488-2020
- FDA event ID
- 86069
- Recalling firm
- Vilvet Pharmaceuticals, Chester Springs, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2020
- FDA classified
- 6 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 24 Jul 2020 | Recall initiated by company | |
| 6 Aug 2020 | Classified by FDA | +13 days |
| 12 Aug 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24.
Where it was distributed
Nationwide within the US
Questions about this recall
Why was it recalled?
cGMP deviations
Which lots are affected?
LOT M823J18-1, M823J18-2, M823J18-3 EXP 09/20; LOT M823D19-1 EXP 04/21
Where was it sold?
Nationwide within the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 86069| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vilamit MB (118 mg methenamine, 36 mg phenyl salicylate recalled | Vilvet Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Vilvet Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vilamit MB (118 mg methenamine, 36 mg phenyl salicylate recalled | Vilvet Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |