Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA drug recalls in 2021

Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,152 recalls, newest first.

Class III · Low risk

Acyclovir Tablets

Labeling: Incorrect or Missing Lot and/or Exp Date

Terminated Labeling / mix-up Heritage Pharmaceuticals Inc NDC 23155-227-01 D-0367-2021
Class I · High risk

BD ChloraPrep Hi-Lite Orange 26 mL Applicator

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

Terminated Packaging defect CareFusion 213, LLC NDC 54365-400-38 D-0373-2021
Class III · Low risk

Evrysdi (risdiplam)

Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.

Terminated Packaging defect Genentech Inc D-0357-2021
Class III · Low risk

Asenapine Sublingual Tablets

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Terminated Other SigmaPharm Laboratories LLC NDC 42794-017-10 D-0380-2021
Class III · Low risk

Asenapine Sublingual Tablets

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Terminated Other SigmaPharm Laboratories LLC NDC 42794-016-10 D-0379-2021

Recalls by year