Recall: D-0867-2026

Class III - Minor Violations

Class IIIClassification

2026-08-27Initiated

OngoingStatus

Macleods Pharmaceuticals LimitFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.