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Drug recall · FDA · Published January 11, 2021

SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun

Sun Pharma recalls testosterone cypionate injections due to incorrect lot numbers on secondary packaging. This may cause confusion in product identification and usage.

🇺🇸 FDA recall #D-0242-2021DrugSun Pharma ›
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Contact the company & request your remedy

Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC2 Independence Way · Princeton, NJ 08540-6620
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sun Pharma is recalling testosterone cypionate injections because the secondary packaging has the wrong lot number. This could lead to confusion about which product is being used, potentially causing incorrect dosing or misuse. Read more at govinfonow.com/recall/36552-sun-pharma-testosterone-cypionate-injection-recall-incorrect-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36552-sun-pharma-testosterone-cypionate-injection-recall-incorrect-labeling-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0242-2021

Cite this page

“Sun Pharma Testosterone Cypionate Injection Recall: Incorrect Labeling Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36552-sun-pharma-testosterone-cypionate-injection-recall-incorrect-labeling-risk. Based on FDA recall #D-0242-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0242-2021%22&limit=1).

Why it’s dangerous

The secondary packaging has an incorrect lot number, which could lead to confusion about the product's identity. This might result in using the wrong product or incorrect dosing if the user is not careful.

Who’s affected

Anyone who has purchased this testosterone injection product from Sun Pharma. Users who rely on precise dosing for medical treatment may be at slightly higher risk due to potential confusion.

How to tell if you have this one

Check for the lot number JKX2553A on the secondary packaging. The product is a 1mL single-dose vial of testosterone cypionate injection, USP CIII : 200mg/ml for intramuscular use only.

  • Brand
    Sun Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the lot number JKX2553A on the secondary packaging to confirm it matches the recalled product.

✎ GovInfoNow

Questions people ask

Is this product dangerous if used correctly?

The recall is due to incorrect labeling, not a safety issue with the product itself. It should be safe if used correctly.

How can I tell if I have the recalled product?

Check for the lot number JKX2553A on the secondary packaging. The product is a 1mL single-dose vial of testosterone cypionate injection, USP CIII: 200mg/ml for intramuscular use only.

Do I need to stop using this product?

No, the recall does not require stopping use. The issue is with labeling, not the product's safety.

Take action

Contact Sun Pharma

We’ve drafted a message you can send Sun Pharma to request your refund or repair — edit it as you like.

Subject: Recall D-0242-2021 — Sun Pharma Sun Pharma

Hello,

I own a Sun Pharma that is covered by recall D-0242-2021 from Sun Pharma.

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-0242-2021 (January 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0242-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA