Class IIReported 2024-12-25

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.

Recalled by Macleods Pharmaceuticals Ltd

Reason for Recall

Failed Impurities/Degradation Specifications

Recall Number

D-0154-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2024-11-25

Reported

2024-12-25

Distribution

Nationwide in the USA

Code Info

Lot# BOB12318A Exp 07/31/2027

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.