FDA Drugs recall ·
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only… recall
- Recall number
- D-0154-2025
- Date
- (initiated November 25, 2024)
- Company / brand
- Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Mumbai, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15,744 30-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Failed Impurities/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# BOB12318A Exp 07/31/2027
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0154-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.