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

Recall Insight

This FDA Drug action (record #D-1166-2022) was formally reported on July 6, 2022, with the manufacturer initiating the action on May 23, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Akcea Therapeutics, Inc. is listed as the recalling firm, operating out of Carlsbad, CA. Federal records indicate 450 cartons units are affected.

The documented reason for this recall is: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). Distribution data in the federal record shows the product reached: KY, USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.