Premier Research Labs Recalls Quantum Gallbladder Support for Undeclared Wheat
Premier Research Labs is recalling Quantum Gallbladder Support capsules because they contain undeclared wheat, a major food allergen.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves undeclared wheat, which is a common allergen. Per the rubric, allergen mislabeling on common allergens corresponds to a High severity score.
Plain-English summary
Premier Research Labs LP is voluntarily recalling approximately 7,101 bottles of Quantum Gallbladder Support. The product consists of 60 capsules in a dark plastic container, with each capsule weighing 460 mg or 427 mg. The specific item number is 12411 and the UPC is 0773512411.
The recall was initiated because the product contains undeclared wheat. Wheat is a major food allergen that can cause severe reactions in sensitive individuals. The affected lot numbers are 111202-12411, 130411-12411, 130612-12411, and 130708-12411.
The affected Gallbladder Support products were distributed in all states in the US as well as internationally to Canada, Ecuador, and Singapore. Consumers should check their inventory for the specific lot numbers listed above. If they possess the affected product, they should stop using it and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411
- Manufacturer
- Premier Research Labs LP
- Category
- Food — Dietary Supplement
- Affected units
- 7,101
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Number: 111202-12411
- 130411-12411
- 130612-12411
- 130708-12411
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Premier Research Labs LP under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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