Olanzapine Tablets recall
FDA recall D-0867-2026 · initiated Aug 27, 2026
Macleods Pharmaceuticals Limited recalled Olanzapine Tablets in Aug 2026 — an FDA Class III recall (D-0867-2026) because Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 22,032 30-count bottles
Details
- 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.
- Recalling company
- Macleods Pharms Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 27, 2026
- FDA report date
- Sep 30, 2026
Frequently asked
- Was Olanzapine Tablets recalled?
- Macleods Pharmaceuticals Limited recalled Olanzapine Tablets in Aug 2026 — an FDA Class III recall (D-0867-2026) because Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Olanzapine Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0867-2026 was: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
- Is a recalled Olanzapine Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Olanzapine Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: BOB22321A, Exp 07-31-2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0867-2026.