Class IIIDrugOngoing

Macleods Pharmaceuticals Limited

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.

Details

Recall number: D-0867-2026
Event ID: 99773
Recall initiated: Aug 27, 2026
Classified: Sep 22, 2026
Reported: Sep 30, 2026
Quantity: 22,032 30-count bottles
Distribution: Nationwide in the USA
Initiated by: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Firm location: Tehsil Baddi, District Solan, India
Lot / code info: Lot: BOB22321A, Exp 07-31-2027.