PlainRecalls
ModerateClass IITerminated

FDA Food recall · Reported April 22, 2015

Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7 09616 01248 2 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.

Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.

Recall #
F-1953-2015
Affected scope
lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles
Initiated
March 13, 2015
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ProThera, Inc. recalled Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement … — a moderate-severity action.

Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement … was recalled by ProThera, Inc. in April 22, 2015. Reason: Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found …. Check the official notice for the remedy. Verify recall #F-1953-2015 with the FDA Food before acting.

The recall

ProThera, Inc. issued this moderate-severity FDA Food recall — Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found ….

Moderate
severity level
Class II
classification
April 22, 2015
reported

Sourced from official FDA Food enforcement records. Verify recall #F-1953-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Food action (record #F-1953-2015) was formally reported on April 22, 2015, with the manufacturer initiating the action on March 13, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. ProThera, Inc. is listed as the recalling firm, operating out of Reno, NV. Federal records list the affected scope as lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles.

The documented reason for this recall is: Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement. Distribution data in the federal record shows the product reached: Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Food — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category — 14,048 drugs & medications recalls on record

-50005001,0001,5002,000 20052009201220152018202120242026 216

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles

Related Recalls

6

1 from same agency

Product description

Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7 09616 01248 2 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.

Reason for recall

Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number F-1953-2015
Date reported April 22, 2015
Date initiated March 13, 2015
Recalling firm ProThera, Inc.
Firm location Reno, NV
Affected scope lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles
Distribution Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (F-1953-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Food before acting — recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7 09616 01248 2 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.. Recalled by ProThera, Inc.. Units affected: lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles.
Why was this product recalled?
Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.
Which agency issued this recall?
This recall was issued by the FDA Food on April 22, 2015. Severity: Moderate. Recall number: F-1953-2015.
Where was the recalled product distributed?
Distribution: Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine..
How do I check if my product is affected by a recall?
Check the product description and recall number (F-1953-2015) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product?
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported April 22, 2015.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.