Macleods Pharmaceuticals Limited recalls Olanzapine Tablets
- Recalling company
- Macleods Pharmaceuticals Limited
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Aug 27, 2026
- Reported
- Sep 30, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 22,032 30-count bottles
- Lot / codes
- Lot: BOB22321A, Exp 07-31-2027.
- Company location
- Tehsil Baddi, District Solan
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0867-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0867-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.