Discolored Product Leads to Recall of Epinephrine Ingredient

Epinephrine (L-adrenaline) is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products.

Spectrum Laboratory Products is voluntarily recalling three lots of epinephrine (L-adrenaline), a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products. Customer complaints have found the product to be discolored.

Epinephrine (L-adrenaline) bulk API powder is used in manufacturing and compounding of epinephrine prescription products, which are used to treat patients with anaphylaxis and other severe immediate hypersensitivity reactions. The use of a finished dose product manufactured or compounded with this recalled product could result in less-effective product.

Spectrum Laboratory Products has not received any reports of adverse events related to this recall.

Epinephrine (L-adrenaline) is packaged in amber glass bottles enclosed in a vacuum sealed pouch. It can be identified by the Spectrum catalog number EP130, and it was distributed directly from facilities nationwide in the United States and to Canada.

The affected lots include:

  • Lot number 1KG0865 with an expiration date of March 31, 2023
  • Lot number 2KL0353 with an expiration date of Sept. 30, 2023
  • Lot number 2KF0151 with an expiration date of March 31, 2023

NDC numbers of the impacted products and package size can be found here.