Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2026

Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

563 recalls, newest first.

Class II · Moderate risk

CAREone

Presence of foreign substance: small metallic particles in chewable tablets.

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. NDC 72476-178-23 D-0566-2026
Class II · Moderate risk

CAREone

Presence of foreign substance: small metallic particles in chewable tablets.

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. NDC 72476-127-80 D-0565-2026
Class II · Moderate risk

Aripiprazole Tablets USP

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

Ongoing Labeling / mix-up Ajanta Pharma USA Inc NDC 27241-056-03 D-0594-2026
Class II · Moderate risk

Alyacen 7/7/7

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Ongoing Impurity / degradation Glenmark Pharmaceuticals Inc., USA NDC 68462-556-29 D-0588-2026
Class II · Moderate risk

Niacin Extended-release Tablets

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

Ongoing Dissolution failure Lannett Company Inc. NDC 62175-322-46 D-0584-2026
Class II · Moderate risk

Xyvona (levorphanol tartrate tablets)

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Ongoing Labeling / mix-up Sun Pharmaceutical Industries INC NDC 72245-058-10 D-0599-2026
Class II · Moderate risk

Xyvona (levorphanol tartrate tablets)

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Ongoing Labeling / mix-up Sun Pharmaceutical Industries INC NDC 72245-762-10 D-0598-2026
Class II · Moderate risk

safco SensiCaine-Ultra

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 67239-0223-1 D-0606-2026
Class II · Moderate risk

PureLife

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 68987-001-30 D-0605-2026
Class II · Moderate risk

Quala Dental Products

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 43128-034-30 D-0601-2026

Recalls by year