Spectrum Labs recalls epinephrine API due to discoloration

Jan. 11, 2023

Spectrum Laboratory Products, a California-based chemical supplier, voluntarily recalled three lots of Epinephrine (L-Adrenaline) USP this week due to discoloration complaints.

In a statement shared by the FDA, the company said that it had received customer complaints about the product becoming discolored, which led to the recall. Epinephrine is a bulk API used to manufacture epinephrine prescription products commonly used to treat severe immediate hypersensitivity reactions brought on by allergic reactions leading to anaphylaxis, asthma, bronchospasm and more.

Although its unclear if the discoloration would cause dosing issues, underdosing epinephrine or using a less effective product could have serious health consequences and could result in death.The company has not received any reports of adverse events related to this recall.

The API powder, which is packaged in amber glass bottles enclosed in a vacuum sealed pouch, was distributed directly from Spectrum facilities nationwide in the U.S. and Canada. The company is contacting its distributors and customers to inform them about the recall. Any consumer, distributor or pharmacy that received Epinephrine USP catalog number EP130 should stop using and/or distributing the product.