All lots of Renadyl probiotic capsules recalled due to undeclared ingredient and missing safety warnings on the label

Last updated:

June 7, 2021
For immediate release

Summary

  • Products: Renadyl probiotic capsules, NPN 80036014
  • Issue: Gelda Scientific and Industrial Development Corporation is recalling all lots of Renadyl because the product contains undeclared inulin and important safety warnings are missing from the product label.
  • What to do: Stop using this product if you have an allergy to inulin or an immune-compromised condition. Talk to a healthcare provider if you have taken a recalled product and have concerns about your health, or for advice on alternatives.

Issue

Gelda Scientific and Industrial Development Corporation is recalling all lots of Renadyl probiotic capsules because the product contains undeclared inulin and important safety warnings are missing from the product label. Renadyl is a probiotic indicated for adult use only.

Inulin can be dangerous for those with inulin allergies. In rare cases, anaphylaxis can occur. Symptoms of anaphylaxis include breathing difficulties, which can be life threatening.

In addition, the following risk statements are missing from the product label:

  • Consult a health care practitioner prior to use if you have nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
  • Discontinue use and consult a health care practitioner if symptoms of digestive upset (e.g. diarrhea) occur, worsen, or persist beyond 3 days
  • Do not use if you have an immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment).

These risk statements are important, especially for those who are immune-compromised as they may be at risk of developing infections after taking probiotics.

The affected products were distributed nationally.

Affected products

Product NPN Lot Expiry
Renadyl probiotic capsules 80036014 5421119B 31-Oct-2021
5420320A 31-Jan-2022
5420720B 30-Jun-2022
5420820 22-Jul-2022
5420221B 31-Jan-2023

What you should do

  • Stop using this product if you have an allergy to inulin or an immune-compromised condition, such as AIDS or lymphoma (cancer), or if you’re undergoing long-term corticosteroid treatment.
  • Talk to a healthcare provider if you have taken a recalled product and have concerns about your health, or for advice on alternatives.
  • Contact Gelda Scientific and Industrial Development Corporation at [email protected] or by calling 905-673-9320 if you have questions about the recall.
  • Report any health product-related side effects or complaints to Health Canada.

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Renadyl probiotic capsules, NPN 80036014

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