Biosimilar Recalled for Distribution of Quarantined Product

Pfizer has issued a voluntary recall of Inflectra (infliximab-dyyb), a biosimilar to Remicade, after a cGMP (current Good Manufacturing Practice) violation led to the inadvertent distribution of product intended for quarantine. The affected product, manufactured by Celltrion, Inc. and distributed under Pfizer Labs, comes in 100 mg single-dose vials packaged in 10 mL containers. A total of 192 vials, identified by lot number 04647349 and with an expiration date of May 31, 2029, are impacted by the recall, which was initiated on January 17, 2025.

The US Food and Drug Administration (FDA) has classified the recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences, although the probability of serious harm is remote. McKesson, a key distributor headquartered in Irving, Texas, has been involved in notifying consignees across the US through formal correspondence. No press release has been issued for the recall, and the case is currently listed as ongoing.

Inflectra is used to treat a range of inflammatory conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. As a TNF (tumor necrosis factor) inhibitor, infliximab biosimilars like Inflectra play a critical role in managing autoimmune diseases by reducing inflammation and slowing disease progression. Pharmacists should be aware of this recall and ensure that any affected inventory is immediately quarantined and returned.