Reported Dec 25, 2024 · Ongoing

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ…

Macleods Pharmaceuticals Ltd.

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: Macleods Pharmaceuticals Ltd · 304 Atlanta Arcade · Mumbai · N/A

Is this the product you have?

  • Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only
  • Manufactured forMacleods Pharma USA, Inc. Princeton, NJ 08540
  • Manufactured forMacleods Pharma USA Inc. Princeton, NJ,08540:
  • Manufactured byMacleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07
Lot codes and dates
  • Lot# BOB12318A Exp 07/31/2027
Amount recalled
15,744 30-count bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

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

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:07 PM UTC

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