Reported Jun 26, 2019 · Terminated

ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India.…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle
  • Manufactured byCadila Healthcare Ltd. Ahmedabad, India
  • Distributed byZydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06
Lot codes and dates

12 of 12 products

Products covered by this recall
#Product as published
1Lot: M706674, M706676, M707685 EXP Jun-19
2M711219, M711220, M711221, M711222, M711269, EXP Sep-19
3M801027, EXP Dec-19
4M801028, M801029, M801030, EXP Jan-20
5M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20
6M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957, M805958, M805959 Apr-20
7M812457, EXP Jul-20, M812458, M812459, M813912, M813913, M813914, M813915, M813916, EXP Aug-20
8M815768, M815769, M818274, EXP Oct-20
9M818119, M818120, M818121, M818635, EXP Nov-20
10M819270, M819861, M819862, EXP Dec-20
11M900921, M900922, M900923, M900924, M900925, EXP Jan-21
12M902634, M902635, EXP Feb-21.
Amount recalled
1,425,264 30-count bottles

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Zydus Pharmaceuticals USA Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 16, 2021 · Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.