# FDA recall D-0154-2025

> **Macleods Pharmaceuticals Ltd** · Class II · drug recall initiated 2024-11-25.

## 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.

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0154-2025
- **Recalling firm:** Macleods Pharmaceuticals Ltd
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-25
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mumbai, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0154-2025

## Citation

> AI Analytics. FDA recall D-0154-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0154-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*