Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries,
Sun Pharmaceutical recalls 200 mg/mL testosterone cypionate injections due to detected particulate matter in vials. This may cause injection site reactions or other issues. Affected products include specific lot numbers and NDC codes.
Lower-risk recall
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling testosterone cypionate injections that contain particulate matter, which could cause injection site reactions or other issues. This recall affects specific vials with a particular lot number and expiration date. Read more at govinfonow.com/recall/40375-sun-pharmaceutical-testosterone-cypionate-injection-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/40375-sun-pharmaceutical-testosterone-cypionate-injection-recall-particulate-matter-hazard · Updated October 6, 2026 · FDA enforcement record: FDA #D-0977-2018
Cite this page
“Sun Pharmaceutical Testosterone Cypionate Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40375-sun-pharmaceutical-testosterone-cypionate-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0977-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0977-2018%22&limit=1).
Why it’s dangerous
Particulate matter in the vials could enter the bloodstream during injection, potentially causing irritation or allergic reactions at the injection site. The presence of foreign particles may also affect the medication's effectiveness.
Who’s affected
People prescribed testosterone cypionate injections by a doctor who received this specific product. Those with medical conditions requiring precise injection techniques may be at slightly higher risk.
How to tell if you have this one
Check for vials labeled 'Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL' with NDC code 62756-016-40 and lot number JKS0280A. Products were distributed by Sun Pharmaceutical Industries, Inc. in the US starting from their manufacturing date.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC code (62756-016-40) and lot number (JKS0280A) on the vial label.
Questions people ask
Is this product safe to use?
The recall states that particulate matter was detected, which could cause injection site reactions or other issues. The product is not safe to use as recalled.
What should I do if I have this product?
Check the NDC code and lot number on the vial label. If it matches the recalled product, contact your doctor or the manufacturer for guidance.
How can I confirm if my product is affected?
Look for the NDC code 62756-016-40 and lot number JKS0280A on the vial label. Products distributed by Sun Pharmaceutical Industries, Inc. in the US are affected.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0977-2018 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0977-2018 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0977-2018 (July 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0977-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.