Lower riskDrug recall · FDA · Published June 3, 2022
Sun Pharmaceutical Testosterone Cypionate Injection Recall: Impurity Risk
Sun Pharmaceutical recalls testosterone cypionate injections due to manufacturing impurities that could affect safety. Affected lots have specific NDC and expiration dates. Consumers should contact pharmacy for details.
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
“Sun Pharmaceutical Testosterone Cypionate Injection Recall: Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34660-sun-pharmaceutical-testosterone-cypionate-injection-recall-impurity-risk. Based on FDA recall #D-1153-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1153-2022%22&limit=1).
Sun Pharmaceutical recalled Testosterone Cypionate Injection, USP due to CGMP deviations that could cause impurity levels to be out of specification. The FDA announced the voluntary Class II recall on June 3, 2022.
How to tell if you have it
Brand: Sun Pharmaceutical
Product: Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton
NDC: 62756-015-40
Lot codes: HAC1974A, HAC1978A
Expiration date: 06/2023
Quantity: 97,450 vials
The hazard
The lots were made with the same active pharmaceutical ingredient as lots rejected due to manufacturing issues. This could cause the product to be out of specification for impurities.
Context
GovInfoNow's records show Sun Pharmaceutical has 93 other recalls on record since May 21, 2013. Other recent recalls include a Nystatin Cream recall for failed stability specifications on Sept. 14, 2026, and a Carbamazepine Tablets recall for black spots from burnt ingredients on Aug. 3, 2026. Similar recent recalls of other injection products include Lupin Ganirelix Acetate Injection (Nov. 13, 2025), Somerset Therapeutics Dexamethasone Injection (Feb. 4, 2026), and Sagent Busulfan Injection (May 4, 2026).
How to tell if you have this one
Check the product label for NDC 62756-015-40. The expiration date is June 2023. This product was distributed by Sun Pharmaceutical and manufactured in India.
Brand
Sun Pharmaceutical
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for NDC 62756-015-40 on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 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-1153-2022 (June 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1153-2022 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.