Reported Jun 24, 2020 · Terminated

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA,…

Aurobindo Pharma USA Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401

Is this the product you have?

  • Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only
  • Manufactured forPrasco Laboratories Mason, OH 45040 USA
  • Manufactured by
    • Aurolife Pharma LLC Dayton
    • NJ 08810
    • NDC 66993-680-30
Lot codes and dates
    • Lot #: 561180046A1
    • Exp 8/2020
Amount recalled
13322 bottles

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/ Degradation Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 10, 2023 · Data as of Sep 19, 6:36 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.