Sun Pharmaceutical Testosterone Injection Recall: Particulate Matter Hazard
Sun Pharmaceutical recalls testosterone cypionate injections due to possible particulate matter. This may cause injection site reactions. Affected products include specific vial sizes and lot numbers.
Lower-risk recall
Presence of Particulate Matter
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling testosterone cypionate injections that may contain particulate matter. This could lead to injection site reactions or other issues if the product is used. Read more at govinfonow.com/recall/41811-sun-pharmaceutical-testosterone-injection-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/41811-sun-pharmaceutical-testosterone-injection-recall-particulate-matter-hazard · Updated October 8, 2026 · FDA enforcement record: FDA #D-0611-2017
Cite this page
“Sun Pharmaceutical Testosterone Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41811-sun-pharmaceutical-testosterone-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0611-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0611-2017%22&limit=1).
Why it’s dangerous
Particulate matter in the injection can cause blockages or reactions at the injection site. This may lead to discomfort or complications if the product is administered.
Who’s affected
People with prescriptions for testosterone cypionate injections from Sun Pharmaceutical. Those using the product for medical purposes are most at risk.
How to tell if you have this one
Check for vials labeled 'Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL' with lot numbers JKR0744A, JKR0745A, JKR0750A, or JKR0795A. Products were distributed by Sun Pharma in the US and manufactured in India.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the specific lot numbers (JKR0744A, JKR0745A, JKR0750A, JKR0795A) on the vial label.
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 13 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-0611-2017 (March 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0611-2017 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.