Recalls / Class II
Class IID-0154-2025
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.
- Brand name
- Olanzapine
- Generic name
- Olanzapine
- Active ingredient
- Olanzapine
- Route
- Oral
- NDCs
- 33342-067, 33342-068, 33342-069, 33342-070, 33342-071, 33342-072
- FDA application
- ANDA202862
- Affected lot / code info
- Lot# BOB12318A Exp 07/31/2027
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Macleods Pharmaceuticals Ltd
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 304 Atlanta Arcade, Church Road, Mumbai, N/A, India
Distribution
- Quantity
- 15,744 30-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-11-25
- FDA classified
- 2024-12-19
- Posted by FDA
- 2024-12-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0154-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.