Kenalog was not pulled from the market for safety or effectiveness concerns. The FDA has explicitly confirmed this. Certain Kenalog formulations, like the topical lotion, were discontinued by their manufacturers for business reasons, while some injectable versions have experienced persistent shortages and back orders. The active ingredient, triamcinolone acetonide, remains available from multiple manufacturers under both the Kenalog brand name and generic labels.
What the FDA Actually Determined
In March 2016, the FDA published a formal determination in the Federal Register stating that Kenalog (triamcinolone acetonide) lotion and several other drug products “were not withdrawn from sale for reasons of safety or effectiveness.” This distinction matters because when a drug is pulled for safety reasons, the FDA moves to block generic versions from being approved. In Kenalog’s case, the opposite happened: the FDA confirmed it would continue approving generic versions of these discontinued products as long as they met standard regulatory requirements.
The discontinued Kenalog products were placed in the “Discontinued Drug Product List” section of the FDA’s Orange Book, which is simply an administrative category for brand-name products no longer being actively marketed. It does not signal a safety problem.
Why Certain Formulations Disappeared
Pharmaceutical companies routinely stop making specific products when they’re no longer profitable, when manufacturing priorities shift, or when a patent expires and generic competition makes the brand-name version commercially unviable. That appears to be the case with several Kenalog products. Bristol-Myers Squibb, the company behind the Kenalog brand, did not publicly provide a reason for shortages of its injectable suspension, according to the American Society of Health-System Pharmacists (ASHP). Other manufacturers have also cycled in and out of the market. Eugia US discontinued its triamcinolone acetonide injection in the 40 mg/mL concentration, and Teva temporarily discontinued its version as well.
These supply disruptions are frustrating for patients and doctors alike, but they reflect manufacturing and business decisions rather than a regulatory crackdown.
The Contamination Scare That Raised Alarm
One event that may have fueled confusion about Kenalog’s safety was a major contamination crisis in 2012 involving a compounding pharmacy called the New England Compounding Center (NECC). NECC produced custom injectable medications, including preservative-free triamcinolone (the same active ingredient in Kenalog), that turned out to be contaminated with bacteria and fungi. The contamination triggered a multistate outbreak of fungal meningitis and other serious infections.
CDC and FDA laboratories identified multiple dangerous organisms in unopened NECC vials, including Aspergillus fumigatus and Bacillus bacteria. NECC recalled all of its products in October 2012, and a related company, Ameridose LLC, followed with its own voluntary recall. This outbreak was tied specifically to NECC’s compounding practices, not to commercially manufactured Kenalog from Bristol-Myers Squibb or other FDA-approved manufacturers. However, the widespread media coverage of contaminated triamcinolone injections likely contributed to public concern about the drug’s safety.
FDA Warnings About Epidural Injections
Another factor that may have shaped the perception that Kenalog was “taken off the market” involves FDA warnings about how injectable corticosteroids, including triamcinolone, are sometimes used. In 2014, the FDA issued a safety communication warning that injecting corticosteroids into the epidural space of the spine could cause rare but serious problems, including loss of vision, stroke, paralysis, and death.
The key detail: the FDA never approved corticosteroids for epidural use in the first place. This was an off-label practice, meaning doctors were using the drug in a way not covered by its original approval. The FDA required updated warning labels on all injectable corticosteroids to describe these risks, but it did not remove the products from sale. Kenalog injections remain approved for their indicated uses, such as treating joint inflammation, allergic conditions, and certain skin disorders.
What’s Available Now
If your doctor previously prescribed Kenalog and you’ve had trouble finding it, the shortage situation has been uneven. Bristol-Myers Squibb has had Kenalog-10, Kenalog-40, and Kenalog-80 on back order at various times with no estimated release date. But triamcinolone acetonide injections remain available from other manufacturers. As of recent ASHP tracking data, Amneal and Mylan (Viatris) both produce triamcinolone acetonide injectable suspensions in the 40 mg/mL concentration across multiple vial sizes. Bristol-Myers Squibb also lists Kenalog-40 in a 10 mL vial as an available product.
Your pharmacy or doctor’s office may need to source from a different manufacturer than they previously used, but the medication itself has not vanished. If you’re told Kenalog is unavailable, ask specifically about generic triamcinolone acetonide in the same formulation and concentration. It is the same drug.