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

Yes — there is an active recall. 6 ongoing FDA recalls mention Anastrozole (54 total). Check the affected lots below.

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

Anastrozole recalls on record

none so far in 2026; 54 on record, newest first
Class II · Moderate risk

Anastrozole Tablets

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Terminated Cross-contamination American Health Packaging NDC 68001-155-04 D-1467-2019
Class II · Moderate risk

Anastrozole Tablets

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Terminated Cross-contamination American Health Packaging NDC 60687-112-21 D-1394-2019
Class II · Moderate risk

Anastrozole Tablets

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Terminated Cross-contamination Zydus Pharmaceuticals USA Inc NDC 68382-209-10 D-1441-2019
Class II · Moderate risk

ANASTROZOLE Tablets

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Terminated Cross-contamination Zydus Pharmaceuticals USA Inc NDC 68382-209-06 D-1440-2019
Class II · Moderate risk

Anastrozole USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8080-1 D-0475-2018
Class II · Moderate risk

Anastrozole SR 1 mg Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0163-2018
Class II · Moderate risk

Anastrozole 0.5 mg Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0161-2018