Omontys Recall Issued by Manufacturer
Last Updated on February 4, 2026
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At A Glance
- This Alert Affects
- Kidney dialysis patients who have been administered the drug Omontys.
- Damages
- Anaphylaxis, serious allergic reactions, death.
- Company(ies)
- Affymax Inc. and Takeda
- Additional Details
- Omontys treats anemia in kidney dialysis patients.
- Date
- On February 24, 2013, Takeda and Affymax announced a recall on all lots of Omontys.
After receiving reports of fatal allergic reactions, the FDA has recommended that Omontys, a drug used to treat anemia, no longer be administered to any dialysis patient. Both companies which manufacture and sell the product have issued a voluntarily recall on Omontys and sent warnings to healthcare professionals and consumers, with instructions on how to return the product. In light of this recall, patients who were injured after receiving the drug may have legal recourse.
Have you or a loved one suffered from a severe allergic reaction after being administered Omontys? If so, you may be eligible to participate in a lawsuit to recover compensation for your injuries.
Omontys Causing Anaphylaxis and Death
The FDA and manufacturing companies have revealed that .2% percent of Omontys users have experienced “hypersensitive reactions” within 30 minutes of administration. A third of these “hypersensitive reactions” were serious, and included anaphylaxis requiring prompt medical attention, and in some cases, hospitalization. The FDA issued a news release following the recall announcement stating that it had received 19 reports of anaphylaxis, which included three fatalities. Since the drug was approved in March of 2012, over 25,000 patients have received treatment with Omontys.
If you or someone you know has been injured by Omontys, you may be entitled to compensation.
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