D-0867-2026 Class III Ongoing
FDA drug recall D-0867-2026 was initiated by Macleods Pharmaceuticals Limited on Aug 27, 2026 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. The recall status is ongoing. Affected quantity: 22,032 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,032 30-count bottles
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot: BOB22321A, Exp 07-31-2027.