CLASS II Drug recall · Reported 26 Jun 2019 · FDA Enforcement Report
Anastrozole Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Anastrozole Tablets, USP, 1 mg, distributed nationwide in the US. The recall was initiated on 6 May 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1441-2019
- FDA event ID
- 82827
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Anastrozole
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 May 2019
- FDA classified
- 1 Jul 2019
- Reported
- 26 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cancer Medication
Timeline
| 6 May 2019 | Recall initiated by company | |
| 26 Jun 2019 | Published in enforcement report | +51 days |
| 1 Jul 2019 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Product as listed by the FDA
Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Anastrozole Tablets, USP, 1 mg recalled?
Yes. Zydus Pharmaceuticals USA recalled Anastrozole Tablets, USP, 1 mg on 6 May 2019. The recall is Class II and its status is Terminated. Recall number D-1441-2019.
Why was it recalled?
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Which lots are affected?
Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
Other Anastrozole recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Anastrozole Tablets, USP, 1 mg, a) recalled by American Health PackagingAnastrozole | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Anastrozole Tablets, 1 mg recalled by Zydus Pharmaceuticals USAAnastrozole | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Anastrozole Tablets, USP, 1mg unit dose blisters recalledAnastrozole | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Anastrozole USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |