Amerisource Health Services CycloSPORINE Capsules Recall: Impurities Risk
Recall of CycloSPORINE Capsules, USP, 100 mg, 30-count blister packs due to impurities. Rx-only product distributed by American Health Packaging. Check NDC 68084-921-25, Lot 154527.
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
Amerisource Health Services is recalling CycloSPORINE Capsules, USP, 100 mg, 30-count blister packs because they failed impurities and degradation tests. This could pose a risk to patients taking immunosuppressants. Read more at govinfonow.com/recall/42043-amerisource-health-services-cyclosporine-capsules-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42043-amerisource-health-services-cyclosporine-capsules-recall-impurities-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0490-2017
Cite this page
“Amerisource Health Services CycloSPORINE Capsules Recall: Impurities Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42043-amerisource-health-services-cyclosporine-capsules-recall-impurities-risk. Based on FDA recall #D-0490-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0490-2017%22&limit=1).
Why it’s dangerous
The capsules failed impurities and degradation tests, meaning they may contain harmful substances not detected in standard quality checks. This could affect patients taking immunosuppressant medications.
Who’s affected
Patients prescribed CycloSPORINE Capsules by a doctor are affected. Those with the specific NDC 68084-921-25 and Lot 154527 are most at risk.
How to tell if you have this one
Check for CycloSPORINE Capsules, USP, 100 mg, 30-count blister packs with NDC 68084-921-25 and Lot 154527. The product is prescription-only and distributed by American Health Packaging.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 68084-921-25 and Lot 154527 on the blister pack.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 8 months 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-0490-2017 (February 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0490-2017 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.