Imuldosa Injections Recalled Due to Lack of Sterility Assurance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Imuldosa (ustekinumab-srlf) injections, 130 mg/26 mL (5 mg/mL). The affected batch has been identified as Lot 004L24A (expires February 2027), affecting 326 vials.
• The recall was initiated by Accord BioPharma, Inc due to a lack of sterility assurance, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Ustekinumab-srlf injections are used to treat plaque psoriasis and psoriatic arthritis as well as Crohn disease and ulcerative colitis.

The FDA has issued a Class II recall for Imuldosa (ustekinumab-srlf) injections, 130 mg/26 mL (5 mg/mL), affecting 326 vials. This product is manufactured and recalled by Accord BioPharma, Inc based in Raleigh, North Carolina. The recall was initiated on June 10, 2026, and received a Class II classification on June 29, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to a lack of assurance of the product’s sterility. This deficiency affects Lot 004L24A, which will expire in February 2027. Accord BioPharma sent out a public notice via letter; no press release has been issued for this recall.

Ustekinumab-srlf injections are prescribed to treat moderate to severe plaque psoriasis and psoriatic arthritis. They can also be used to treat patients with moderate to severe active Crohn disease and ulcerative colitis. Pharmacists should identify and quarantine Lot 004L24A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 8, 2026. Accessed July 8, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221079