The Recall Desk
HighFDA (Food)·F-1954-2015·Announced 2015-04-22

ProThera Recalls Ther-Biotic Probiotic Supplements Due to Glass Shards

ProThera, Inc. is recalling three lots of Ther-Biotic Children's Chewable probiotic supplements because shards of blue glass were found in the bottles.

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 risk-of-harm product (glass shards) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

ProThera, Inc. is recalling three lots of Ther-Biotic Children's Chewable 125+ Billion CFU's Multi-Species Probiotic Supplement. The recall involves 60-chewable capsule bottles with Lot Number J4694 and an expiration date of 12/15. The firm is recalling the product due to reports of shards of blue glass found in the bottles, rather than in the supplement itself.

The affected product was distributed nationwide and to Azerbaijan, Canada, China, Germany, Great Britain, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, and Ukraine. A total of 3,484 bottles were involved in the distribution.

Consumers should stop using the recalled product and contact ProThera, Inc. for instructions on how to return the product or obtain a refund.

The recalled product

Product
Klaire Labs Ther-Biotic Children's Chewable 125+ Billion CFU's Multi-Species Probiotic Supplement 60 Chewable Capsules. UPC 7 09616 01247 5 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.
Manufacturer
ProThera, Inc.
Affected units
3,484

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 (2)

  • K-TCC (60 capsules) Lot Number: J4694
  • Exp 12/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →