Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Tegsedi (inotersen) Injection 284 mg/1.5 mL Recalled by Akcea Therapeutics, Inc. Due to Superpotent: High Out of specification (OOS) test result...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Akcea Therapeutics, Inc. directly.
Affected Products
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01
Quantity: 450 cartons
Why Was This Recalled?
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Where Was This Sold?
This product was distributed to 1 state: KY
About Akcea Therapeutics, Inc.
Akcea Therapeutics, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report