FDA Drugs recall ·
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only… recall
- Recall number
- D-0867-2026
- Date
- (initiated August 27, 2026)
- Company / brand
- Macleods Pharmaceuticals Ltd
Village Theda, Tehsil Baddi, District Solan, India - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 22,032 30-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: BOB22321A, Exp 07-31-2027.
Distribution
Nationwide in the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0867-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.