CLASS II Food recall · Reported 10 Dec 2014 · FDA Enforcement Report

BiliVen in dark, each capsule is 460 mg or 427 mg each) recalled

Premier Research Labs is recalling Premier Research Labs BiliVen in dark, each capsule is 460 mg or 427 mg each), distributed nationwide in the US. The recall was initiated on 22 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 111202-2411, 130411-2411, 130612-2411, 130708-2411; UPC 0773502411

Quantity recalled49,830 bottles

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: F-0592-2015
FDA event ID: 69561
Recalling firm: Premier Research Labs, Austin, TX
Brand: Premier Research
Classification: Class II
Status: Terminated
Recall initiated: 22 Oct 2014
FDA classified: 1 Dec 2014
Reported: 10 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Undeclared Wheat & Gluten
Product category: Dietary Supplements

Timeline

22 Oct 2014	Recall initiated by company
1 Dec 2014	Classified by FDA	+40 days
10 Dec 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Undeclared wheat

Product as listed by the FDA

Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411

Where it was distributed

Gallbladder Support products were distributed in all states in the US as well as internationally to Canada, Ecuador, and Singapore. BiliVen products were distributed in all states in the US as well as internationally to Canada, Hong Kong, Ireland, New Zealand, Singapore, United Arab Emirates, United Kingdom, Australia, Bermuda, Fiji, and Israel.

Nationwide

Questions about this recall

Is BiliVen in dark, each capsule is 460 mg or 427 mg each) recalled?

Yes. Premier Research Labs recalled BiliVen in dark, each capsule is 460 mg or 427 mg each) on 22 Oct 2014. The recall is Class II and its status is Terminated. Recall number F-0592-2015.

Why was it recalled?

Undeclared wheat

Which lots are affected?

Lot Number: 111202-2411, 130411-2411, 130612-2411, 130708-2411; UPC 0773502411

Where was it sold?

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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