FDA recall D-0867-2026

Product

Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.

Reason for recall

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-08-27

Report date

2026-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tehsil Baddi, District Solan, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0867-2026