Sun Pharmaceutical recalls testosterone injections due to potential contamination from a manufacturing issue. Affected lots may pose a risk of infection if used.
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Sun Pharmaceutical is recalling testosterone injections that may contain contaminants due to a manufacturing problem. Using these products could lead to infections if the injection is not sterile.
The injection was made in a facility where a microbial contamination event occurred. This means the product might not be sterile, increasing the risk of infection when injected.
People prescribed testosterone injections by a doctor who received the recalled product. Those with compromised immune systems are at slightly higher risk.
Check the product label for the lot number HAC3427A and expiration date 08/2023. The product is a 200 mg/mL, 1 mL single-dose vial per carton, prescription-only injection.
Look for the lot number HAC3427A and expiration date 08/2023 on the vial.
The product may not be sterile due to a manufacturing issue, so it should not be used.
Check the product label for the lot number HAC3427A and expiration date 08/2023. If it matches, contact your doctor for guidance.
The recall record does not specify a replacement process.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-1154-2022 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-1154-2022 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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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.
