Lower riskDrug recall · FDA · Published June 21, 2022
Sun Pharmaceutical Testosterone Injection Recall: Water Leakage Hazard
Sun Pharmaceutical recalls 200mg/mL Testosterone Cypionate Injection vials due to water leakage risk. This could affect product safety and efficacy. Consumers should check NDC 62756-015-40 for affected units.
“Sun Pharmaceutical Testosterone Injection Recall: Water Leakage Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34612-sun-pharmaceutical-testosterone-injection-recall-water-leakage-hazard. Based on FDA recall #D-1190-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1190-2022%22&limit=1).
The FDA announced on June 21, 2022, that Sun Pharmaceutical Industries Inc. voluntarily recalled 50,860 vials of Testosterone Cypionate Injection due to cGMP water leakage hazards. The recall was classified as Class II and has since been terminated.
The recall addresses current Good Manufacturing Practice (cGMP) violations involving water leakage in the product packaging. The FDA classified this as a Class II recall, indicating a moderate risk of serious adverse health consequences or death.
Context
GovInfoNow's records show Sun Pharmaceutical Industries Inc. has 93 other recalls on record since May 21, 2013. Recent brand recalls include Nystatin Cream with failed stability specifications on Sept. 14, 2026, and Carbamazepine Tablets containing black spots from burnt ingredients on Aug. 3, 2026. Other recent recalls of similar products include Teva Testosterone Gel 1% risk of leakage (Nov. 7, 2025) and Novocol OraVerse Injection cracked cartridges risk (Oct. 31, 2025).
How to tell if you have this one
Check for the NDC code 62756-015-40 on the vial label. The product is a 1mL single-dose vial for prescription use only.
Brand
Sun Pharmaceutical
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Label
Look for the NDC code 62756-015-40 on the vial label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA 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 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1190-2022 (June 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1190-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.