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

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

Recall #: D-1166-2022
Affected scope: 450 cartons
Initiated: May 23, 2022

Compiled from official public sources by the publisher. · Updated September 2026

Akcea Therapeutics, Inc. recalled Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous U… - a critical-severity action.

Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous U… was recalled by Akcea Therapeutics, Inc. in July 6, 2022. Reason: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).. Check the official notice for the remedy. Verify recall #D-1166-2022 with the FDA Drug before acting.

The recall

Akcea Therapeutics, Inc. issued this critical-severity FDA Drug recall-Superpotent: High Out of specification (OOS) test result for percent label claim (%LC)..

Critical
severity level: Class I
classification: July 6, 2022
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1166-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Reason for recall

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	D-1166-2022
Date reported	July 6, 2022
Date initiated	May 23, 2022
Recalling firm	Akcea Therapeutics, Inc.
Firm location	Carlsbad, CA
Affected scope	450 cartons
Distribution	KY, USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-1166-2022) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on July 6, 2022. Severity: Critical. Recall number: D-1166-2022.

Where was the recalled product distributed? ▼

Distribution: KY, USA.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported July 6, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026