The Recall Desk
HighFDA (Food)·F-0159-2014·Announced 2013-11-20

Klaire Labs Vital-Zymes Chewable Recalled for Chloramphenicol Contamination

ProThera, Inc. is recalling Klaire Labs Vital-Zymes Chewable enzyme supplements because they may be contaminated with chloramphenicol.

What this means for you

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 involves a high-risk contaminant (chloramphenicol) in a dietary supplement without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ProThera, Inc. is recalling specific lots of Klaire Labs Vital-Zymes Chewable Comprehensive Enzyme Supplements. The recall involves 82,746 units of lot F3990 and 988,200 units of lot C3516. The product is a 180-count chewable tablet supplement manufactured by ProThera, Inc., a division of which Klaire Labs is part, located in Reno, Nevada.

The recall was initiated after ProThera was notified that enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol. Chloramphenicol is an antibiotic that is generally not permitted in dietary supplements due to potential health risks.

The affected products were distributed in the United States and internationally, including Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, and Thailand. Consumers should check their products for lot numbers F3990 or C3516 and discontinue use if they match these lots.

The recalled product

Product
Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
Manufacturer
ProThera, Inc.

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 (1)

  • Lot F3990 and C3516

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by ProThera, Inc. 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 5 products in this recall →