Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Nov 16, 2017 (9 years ago)

Anastrozole 0.5 mg Capsules

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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.

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Drug: Anastrozole

Recalling firm
KRS Global Biotechnology, Inc
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0161-2018 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Anastrozole recalls

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Presence of Foreign substance - potential presence of metal particulate matter

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Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

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Other recalls by KRS Global Biotechnology, Inc

All 2017 recalls