Zydus Recalls Anastrozole Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Anastrozole tablets due to cross-contamination from cleaning failures. The recall covers 1.4 million bottles distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) per the rubric, as it involves a potential health risk from cross-contamination.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Anastrozole Tablets, 1 mg, 30-count bottles, due to Current Good Manufacturing Practice (CGMP) deviations. The recall is caused by cross-contamination with other products resulting from a cleaning failure.
The affected product is Anastrozole, a prescription-only medication manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ. The recall includes 1,425,264 30-count bottles distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall notice, ranging from June 2019 to February 2021.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- ANASTROZOLE (ANASTROZOLE)
- Brand
- ANASTROZOLE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
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 (20)
- Lot: M706674
- M706676
- M707685 EXP Jun-19
- M711219
- M711220
- M711221
- M711222
- M711269
- EXP Sep-19
- M801027
- EXP Dec-19
- M801028
- M801029
- M801030
- EXP Jan-20
- M802206
- EXP Feb-20
- M805195
- M805196
- M805197
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
- ModerateZydus Recalls Anastrozole Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
- SevereAmerican Health Packaging Recalls Anastrozole Tablets Due to Cleaning Failures
FDA (Drugs) · 2019-06-26
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