Elite Laboratories Isradapine Capsules Recall: Failed Impurities Risk
Elite Laboratories recalls Isradapine Capsules USP 2.5 mg 100-count bottles (Rx only) due to failed impurities/degradation specifications. No remedy stated in official notice.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Elite Laboratories is recalling Isradapine Capsules USP 2.5 mg 100-count bottles (Rx only) because they failed impurities and degradation specifications. This could pose a risk to users taking the medication. Read more at govinfonow.com/recall/41097-elite-laboratories-isradapine-capsules-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41097-elite-laboratories-isradapine-capsules-recall-failed-impurities-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0107-2018
Cite this page
“Elite Laboratories Isradapine Capsules Recall: Failed Impurities Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41097-elite-laboratories-isradapine-capsules-recall-failed-impurities-risk. Based on FDA recall #D-0107-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0107-2018%22&limit=1).
Why it’s dangerous
The capsules failed impurities and degradation specifications, which could mean the medication is unsafe for use. This might cause harm to users who take the medication as prescribed.
Who’s affected
Prescription users of Isradapine Capsules USP 2.5 mg 100-count bottles from Elite Laboratories. People with this medication prescription are most at risk.
How to tell if you have this one
Check for Isradapine Capsules USP 2.5 mg, 100-count bottles with NDC 42806-263-01, UPC 342806263013, and lot number P0910-017 (expiring May 2019).
- Brand
Elite Laboratories- Product
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 42806-263-01, UPC 342806263013, and lot number P0910-017 on the bottle.
Where it went and when
Where it was distributed
Distributed in New York.
FDA distribution: “NY only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0107-2018 (November 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0107-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.