Azurity Pharmaceuticals recalls Testosterone Cypionate Injection due to crystals not redissolving after warming. This affects specific vial sizes and lots. Contact for details.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection vials that may have crystals not redissolving after warming. This could lead to improper dosing if the injection isn't properly prepared.
The vials may contain crystals that don't dissolve properly when warmed and shaken. This could cause inconsistent dosing if the injection isn't correctly prepared.
People who have the specific vial sizes (10 mL multiple-dose or 1 mL single-dose) with the listed lot numbers. Those using the product for medical purposes are most at risk.
Check for vials labeled 10 mL multiple-dose (NDC 52536-625-10) or 1 mL single-dose (NDC 52536-625-01) with lot numbers 23804.034A or 23803.061A. The product expires September 2024.
Identify the vial size and lot number to confirm if it's affected.
The recall is due to potential crystals not redissolving after warming, which could affect dosing. Use only the unaffected vials.
The official recall does not specify a remedy, so contact Azurity Pharmaceuticals for guidance.
Look for vials with NDC 52536-625-10 (10 mL) or 52536-625-01 (1 mL) and lot numbers 23804.034A or 23803.061A.
We’ve drafted a message you can send Azurity to request your refund or repair — edit it as you like.
Subject: Recall D-0489-2023 — Azurity Azurity Hello, I own a Azurity that is covered by recall D-0489-2023 from Azurity. 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.