Apotex CycloSPORINE Capsules Recall: Impurities May Cause Harm
Apotex recalls 100mg CycloSPORINE Capsules due to impurities that could cause harm. Affected lots manufactured in Canada, expire July 2017. Consumers should contact Apotex for details.
Recall notice
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Contact the company
What happened, in plain English
Apotex is recalling 100mg CycloSPORINE Capsules that may contain harmful impurities. This could cause health issues for people taking the medication. The recall affects specific lots manufactured in Canada with an expiration date of July 2017. Read more at govinfonow.com/recall/42056-apotex-cyclosporine-capsules-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/42056-apotex-cyclosporine-capsules-recall-impurities-may-cause-harm · Updated October 8, 2026 · FDA enforcement record: FDA #D-0475-2017
Cite this page
“Apotex CycloSPORINE Capsules Recall: Impurities May Cause Harm.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42056-apotex-cyclosporine-capsules-recall-impurities-may-cause-harm. Based on FDA recall #D-0475-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0475-2017%22&limit=1).
Why it’s dangerous
The capsules may contain impurities that exceed safe levels. These impurities could cause health problems, especially for people with kidney issues or those on immunosuppressant therapy. The exact health risks are not specified in the recall.
Who’s affected
People with a prescription for CycloSPORINE Capsules who own the recalled product. Those with kidney issues or on immunosuppressant therapy are at higher risk.
How to tell if you have this one
Check for the product name 'CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only'. Look for the lot number MJ9837 and expiration date of July 2017 on the packaging.
- Brand
Apotex- Product
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number MJ9837 and expiration date of July 2017 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0475-2017 (February 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0475-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.