Invega Syringe Lawsuit | 2026 Latest Updates

Janssen Inc., a Johnson & Johnson subsidiary, voluntarily recalled prefilled syringes of Invega Sustenna in February 2011. Testing found cracks in the syringe barrel, not visible under the label. About 70,000 syringes were pulled from US distribution. Press reports linked the crack to a possible risk of infection or reduced drug effectiveness. Anyone holding an affected syringe should confirm the lot with a prescriber or pharmacy before use. Health Canada posted the recall notice on March 7, 2011. No later termination, expansion or reannouncement notice has been located for it, so the recall is treated as open. Readers with an affected syringe should follow the steps below.

Latest Invega Syringes Recall Updates

March 15, 2021: FDA Records a Separate, Smaller Recall

On March 15, 2021, the FDA recorded a separate Class II recall of 534 Invega Sustenna syringes at a different, 156 mg strength [1]. Distributor Cardinal Health Inc. initiated it over intermittent temperature-excursion deviations during storage (CGMP). The syringes were distributed to Florida, Georgia and South Carolina. This recall is separate from, and later than, the 2011 syringe-crack recall this page covers.

February 9, 2011: Janssen Recalls Invega Sustenna Syringes over Cracks

Janssen Inc., a J&J subsidiary, recalled prefilled Invega Sustenna syringes on February 9, 2011, according to Health Canada’s recall notice. The syringes had reached wholesalers, retailers, hospitals, doctors’ offices and clinics before the recall began. Health Canada posted the notice on March 7, 2011, covering the 150 mg strength. US coverage from Law360 reported about 70,000 syringes recalled, citing a possible infection risk [2].

Which Invega Syringes Are Affected?

The recall covers prefilled Invega Sustenna syringes identified by strength and lot number:

• United States: a 234 mg strength is reported, but not confirmed by any source read for this page. Specific lot numbers have not been published either.
• Canada: the 150 mg strength, DIN 02354241, lot 9HBK000, recalled under Health Canada’s notice.

Check the syringe label, the outer carton, or a pharmacy record for the strength and lot number before use, or ask the prescriber or pharmacy that supplied it. A prescriber or pharmacy can confirm whether a specific syringe matches the recalled lot against the official notice, since exact US expiration dates were not published.

Why Were the Invega Syringes Recalled?

Invega Sustenna syringes were recalled because testing found a crack in the syringe barrel. Blue-dye ingress testing on 1.5 mL, filled and labeled syringes revealed the defect, not visible without removing the label. Health Canada’s notice states that Janssen found the crack during stability-monitoring testing. It also classified the recall as a Type I hazard, its most serious category. A Wall Street Journal wire report carried by BioSpace described the defect as a possible source of infection or reduced efficacy [3]. No 2011 record of this recall exists in the FDA’s public enforcement database. The earliest related record is the unrelated, later Cardinal Health recall covered above.

Reported Incidents, Injuries, or Illnesses

Health Canada’s recall notice does not report any confirmed infection, injury, or death linked to a cracked syringe. It also gives no reporting cutoff date or geographic breakdown of complaints. Law360 and a BioSpace-carried wire report state no incident count. That silence does not confirm zero incidents occurred. It means no source states an incident count, in either direction, as of the review date. Anyone who received an injection from an affected syringe and later developed signs of infection should tell a healthcare provider. Reporting the concern to Health Canada or the FDA is also an option, particularly if symptoms persist or worsen.

What Should Consumers Do?

Anyone who received or was given an Invega Sustenna syringe can take the following steps:

1. Ask your prescriber or pharmacy whether your dose came from the recalled lot before it is used.
2. Do not use or administer a syringe confirmed to be part of the recalled lot.
3. Watch for redness and pain, fever, or drainage at the injection site. Contact a healthcare provider if any of these appear, per CDC guidance on infection signs [4].
4. Contact the FDA or Health Canada to report a concern about this recall.
5. For questions about a specific syringe, contact the prescribing office, since Janssen has not published a direct patient phone or email line.

Legal Options

Schmidt & Clark is reviewing potential claims from people who received an injection from a recalled Invega Sustenna syringe. The review covers those who experienced the infection or efficacy problems described above. No class action or multidistrict litigation has been filed over this syringe-crack defect. A recall does not automatically establish liability or eligibility for compensation.

Filing Deadlines

State law sets the deadline for a product-liability claim. No single national rule applies. The window can depend on your home state and on when an infection, reduced-efficacy episode, or its diagnosis took place. Missing that window can end a claim regardless of its strength, so early legal advice matters, especially soon after a diagnosis.

Frequently Asked Questions

What Are the Symptoms of an Infection from a Cracked Invega Syringe?

Symptoms of an infection from a cracked Invega syringe include the redness, pain, fever, and drainage covered in the consumer steps above. CDC guidance also notes that other signs and symptoms can occur beyond that list. Contact a healthcare provider promptly about any sign near the injection site.

Is the Invega Sustenna Syringe Recall Still Active?

The 2011 Invega Sustenna syringe recall has no closure notice on record, so it is treated as still open. A separate, later Cardinal Health recall of a different 156 mg strength was terminated on June 17, 2024. That closure does not apply to the 2011 recall covered here.

Are Exact US Lot Numbers Available for the Invega Syringe Recall?

Exact US lot numbers for the Invega syringe recall have not been published in any public notice read for this page. Only Health Canada’s notice lists an identifier for the Canadian syringes, covered above. No US regulator or manufacturer notice for this 2011 recall was located.

Can I File a Claim over an Infection from a Recalled Invega Syringe?

You may be able to file a claim if you experienced the infection or efficacy problems described above after a recalled Invega syringe. Schmidt & Clark offers a free case review, though it does not promise eligibility or any result.

Were Invega Syringes Recalled in Canada?

Invega Sustenna syringes were recalled in Canada: Health Canada’s February 2011 notice covers the strength and lot detailed in the affected-products list above. That recall is separate from the unrelated 2021 Cardinal Health recall of a different, 156 mg strength.

Does Janssen Offer a Refund or Replacement for Recalled Invega Syringes?

Janssen’s recall notice does not describe a patient refund or replacement process for recalled Invega syringes. The notice lists Janssen’s address as 19 Green Belt Drive, Toronto, Ontario. It lists no patient phone number or email address, so contact the prescribing office or the FDA or Health Canada instead.

References

1. https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0498-2021%22
2. https://www.law360.com/articles/226298/j-j-unit-recalls-antipsychotic-syringes-over-cracks
3. https://www.biospace.com/johnson-and-johnson-recalls-70-000-invega-syringes
4. https://www.cdc.gov/surgical-site-infections/about/index.html