FDA Removes Unapproved Prescription Drug Products Containing Codeine and Dihydrocodeine from the Market

The U.S. Food and Drug Administration (FDA) has ordered companies to stop manufacturing and distributing unapproved prescription drug products containing codeine and unapproved prescription drug products containing dihydrocodeine as of February 24, 2014 and April 10, 2014, respectively. 

The drugs covered by this action lack the required FDA approval and are:

• single-ingredient codeine sulfate oral tablets;
• single-ingredient codeine phosphate injections;
• combination products containing codeine phosphate; and
• combination products containing dihydrocodeine bitartrate.  

For historical reasons, some prescription drug products are available in the United States but lack FDA approval for marketing.  FDA is taking this action as part of the Agency’s continuing effort to ensure that prescription drugs marketed in the United States  have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and are appropriately labeled. 

According to the FDA, the announced removal  is not a recall, and previously manufactured unapproved drug products affected by this action may still be found on pharmacy shelves for a short period of time (until the inventory has been depleted or until the products’ expiration date).

Read FDA’s Q&A on the removal of these products from the market.