Zydus Recalls Anastrozole Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling 768 bottles of Anastrozole 1 mg tablets due to cross-contamination from a cleaning failure.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is cross-contamination, which is a quality control issue rather than a high-risk pathogen or structural defect.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 768 1,000-count bottles of Anastrozole Tablets, USP, 1 mg. The product is a prescription-only medication manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ. The recall covers specific lots with expiration dates ranging from June 2019 to August 2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross-contamination with other products resulting from a cleaning failure. The affected product was distributed nationwide in the USA.
Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Consumers should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.
The recalled product
- Product
- ANASTROZOLE (ANASTROZOLE)
- Brand
- ANASTROZOLE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot EXP Date: M708570 Jun-19
- M711270 Sep-19
- M802207 Feb-20
- M812460 Aug-20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same brand · ANASTROZOLE
- ModerateAmerican Health Packaging Recalls Anastrozole Tablets Due to GMP Deviations
FDA (Drugs) · 2019-07-17
- SevereAmerican Health Packaging Recalls Anastrozole Tablets Due to Cleaning Failures
FDA (Drugs) · 2019-06-26
- SevereZydus Recalls Anastrozole Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
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