CLASS II Drug recall · Reported 12 Aug 2020 · FDA Enforcement Report

Vilamit MB (118 mg methenamine, 36 mg phenyl salicylate recalled

Vilvet Pharmaceuticals is recalling Vilamit MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate, 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

Lot, batch or date codesLOT M824H18-1 EXP 08/20 LOT M824J18-1 EXP 09/20 LOT M824L18-1 EXP 11/20 LOT M824A19-1 EXP 01/21 LOT M824C19-1 EXP 03/21 LOT M824G19-1 EXP 07/21

Quantity recalled11,640 bottles

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-1487-2020
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

VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.

Where it was distributed

Nationwide within the US

Nationwide

Questions about this recall

Why was it recalled?

cGMP deviations

Which lots are affected?

LOT M824H18-1 EXP 08/20 LOT M824J18-1 EXP 09/20 LOT M824L18-1 EXP 11/20 LOT M824A19-1 EXP 01/21 LOT M824C19-1 EXP 03/21 LOT M824G19-1 EXP 07/21

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

This product is part of a recall event; the main page for the event is Vilevev MB Urinary Antispetic (81.0 mg methenamine recalled.

Reported	Class	Recall	Company	Reason	Where
12 Aug 2020	CLASS II	Vilevev MB Urinary Antispetic (81.0 mg methenamine recalled	Vilvet Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Vilvet Pharmaceuticals

All 2

Reported	Class	Recall	Company	Reason	Where
12 Aug 2020Drug	CLASS II	Vilevev MB Urinary Antispetic (81.0 mg methenamine recalled	Vilvet Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide