Akcea Therapeutics, Inc. recalls Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each
Akcea Therapeutics recalls Tegsedi (inotersen) injection due to high out-of-specification test results for label claim percentage. Affected units include specific NDC and expiration dates. Contact for remedy details.
Lower-risk recall
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Contact the company & request your remedy
What happened, in plain English
Akcea Therapeutics has recalled Teg:edi injections that failed a critical quality test. This means the product may not contain the labeled amount of active ingredient, which could affect treatment effectiveness. Read more at govinfonow.com/recall/34673-akcea-tegsedi-injection-recall-high-label-claim-test-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/34673-akcea-tegsedi-injection-recall-high-label-claim-test-failure · Updated September 23, 2026 · FDA enforcement record: FDA #D-1166-2022
Cite this page
“Akcea Tegsedi Injection Recall: High Label Claim Test Failure.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34673-akcea-tegsedi-injection-recall-high-label-claim-test-failure. Based on FDA recall #D-1166-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1166-2022%22&limit=1).
Why it’s dangerous
The product failed a test that measures how much active ingredient it should contain. This could mean the dose is lower than labeled, potentially reducing treatment effectiveness. However, the recall does not indicate immediate safety risks like injury or death.
Who’s affected
Prescription patients using Tegsedi injections for hereditary transthyretin amyloidosis. Those with the specific NDC number 72126-007-01 and expiration dates through May 2025 are most at risk.
How to tell if you have this one
Check for the NDC number 72126-007-01 on the product label. The product was distributed by Sobi, Inc. in Waltham, MA, with expiration dates through May 2025.
- Brand
Akcea Therapeutics- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC number 72126-007-01 and expiration date up to May 2025 on the Tegsedi injection packaging.
Questions people ask
Is this product safe to use?
The recall indicates a test failure for label claim percentage, but the product is not unsafe. It may have lower active ingredient than labeled, affecting treatment effectiveness.
What should I do if I have this product?
The recall does not specify a remedy, so contact Akcea Therapeutics directly for guidance on next steps.
How can I tell if I have the recalled product?
Check for the NDC number 72126-007-01 and expiration date through May 2025 on the product label.
Contact Akcea Therapeutics
We’ve drafted a message you can send Akcea Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-1166-2022 — Akcea Therapeutics Akcea Therapeutics Hello, I own a Akcea Therapeutics that is covered by recall D-1166-2022 from Akcea Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1166-2022 (May 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1166-2022 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.