Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Allopurinol recalled?

Not under an active recall. Allopurinol was recalled 7 times in the past — all now closed. Most recent: Jun 7, 2024.

Most common reason: Particulate / foreign matter (3 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Allopurinol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Allopurinol recalls on record

none so far in 2026; 7 on record, newest first
Class II · Moderate risk

Allopurinol Tablets 100mg

Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Terminated Particulate / foreign matter Preferred Pharmaceuticals, Inc. D-0173-2023
Class II · Moderate risk

Allopurinol Tablets USP

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Terminated Particulate / foreign matter Accord Healthcare, Inc. NDC 16729-134-01 D-0168-2023
Class II · Moderate risk

ALLOPURINOL Tablets

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0164-2024
Class II · Moderate risk

Aloprim (allopurinol sodium)

Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.

Terminated Failed specification Mylan Institutional LLC D-1271-2020
Class III · Low risk

Allopurinol Tablets

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Terminated Failed specification Qualitest Pharmaceuticals NDC 0603-2116-28 D-1405-2015
Class II · Moderate risk

ALLOPURINOL Tablet

Labeling: Label Mixup; ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD52993_25, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-515-2014