Lower riskDrug recall · FDA · Published February 15, 2023
Azurity Testosterone Cypionate Injection Recall: Crystals May Not Redissolve
Azurity Pharmaceuticals recalls Testosterone Cypionate Injection due to crystals not redissolving after warming. This affects specific vial sizes and lots. Contact for details.
“Azurity Testosterone Cypionate Injection Recall: Crystals May Not Redissolve.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33875-azurity-testosterone-cypionate-injection-recall-crystals-may-not-redissolve. Based on FDA recall #D-0489-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0489-2023%22&limit=1).
The FDA announced on Feb. 15, 2023, that Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection due to cGMP violations involving crystals not redissolving in vials. The recall affects lots expiring in September 2024 distributed nationwide.
Packaging: 10 mL multiple-dose vials (NDC 52536-625-10) and 1 mL single dose vials (NDC 52536-625-01)
Lot codes: 23804.034A, 23803.061A
Expiration date: 9/2024
Manufacturer: Wilshire Pharmaceuticals, Inc., Atlanta, GA
The hazard
The FDA stated the hazard involves complaints of crystals not redissolving into solution after warming and shaking the vials. This issue is classified as a cGMP violation.
Context
GovInfoNow's records show Azurity Pharmaceuticals, Inc. has had three other recalls since Aug. 24, 2021, including a Jan. 4, 2024 Zenzedi label mix-up and a Dec. 8, 2023 Eprontia impurity risk. Other recent recalls of similar products include an Oct. 14, 2025 FarmaKeio testosterone pellet recall for metal particulate risk and a March 13, 2026 Endo USA buprenorphine injection recall for crystallization risk.
How to tell if you have this one
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.
Brand
Azurity
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Details
Identify the vial size and lot number to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US 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 10 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-0489-2023 (February 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0489-2023 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.