Skip to content
Back to recalls
Drug FDA Class II Ongoing Failed specifications

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

Macleods Pharmaceuticals Ltd Published Dec 25, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Macleods Pharmaceuticals Ltd or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Impurities/Degradation Specifications

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

OLANZAPINE · 15,744 30-count bottles

NDC: 33342-067, 33342-068, 33342-069, 33342-070, 33342-071, 33342-072, 33342-067-07, 33342-067-44, 33342-067-12, 33342-067-11, 33342-068-07, 33342-068-44, 33342-068-12, 33342-068-11, 33342-069-07, 33342-069-44, 33342-069-12, 33342-069-11, 33342-070-07, 33342-070-15, 33342-070-12, 33342-070-44, 33342-070-11, 33342-071-07, 33342-071-15, 33342-071-12, 33342-071-44, 33342-071-11, 33342-072-07, 33342-072-15, 33342-072-12, 33342-072-44, 33342-072-11
Lot codes: BOB12318A
Code info: Lot# BOB12318A Exp 07/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 25, 2024
  2. Published
    Dec 25, 2024
Recall number
D-0154-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.