Macleods Olanzapine Tablets 10mg Recall: Cgmp Deviations
Macleods Pharma USA recalls 10mg Olanzapine tablets due to cGMP deviations. Affected lots: BOB42029A, BOB4202B. Expired 09/2022. No specific remedy stated in recall.
Recall notice
cGmp Deviations
Contact the company
What happened, in plain English
Macleods Pharma USA is recalling 10mg Olanzapine tablets that were manufactured with cGMP deviations. This means the product may not meet quality standards, but the recall does not specify a remedy or how to check if you have the affected product. Read more at govinfonow.com/recall/35215-macleods-olanzapine-tablets-10mg-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/35215-macleods-olanzapine-tablets-10mg-recall-cgmp-deviations · Updated August 18, 2026 · FDA enforcement record: FDA #D-0639-2022
Cite this page
“Macleods Olanzapine Tablets 10mg Recall: Cgmp Deviations.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35215-macleods-olanzapine-tablets-10mg-recall-cgmp-deviations. Based on FDA recall #D-0639-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0639-2022%22&limit=1).
Why it’s dangerous
The product was made with cGMP deviations, which are quality control issues in manufacturing. This could mean the tablets may not be safe or effective, but the recall does not specify what harm could occur.
Who’s affected
Prescription users of Olanzapine tablets in the US who purchased the specific lots mentioned. People with mental health conditions requiring this medication are most at risk if they use the recalled product.
How to tell if you have this one
Check for the lot numbers BOB42029A or BOB4202B on the packaging. The product expires September 2022 and is sold as a 30-count bottle for prescription use only.
- Brand
Macleods- Category
Drug
What to do — step by step
Check Product Lot Number
Look for lot numbers BOB42029A or BOB4202B on the packaging of the Olanzapine tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0639-2022 (February 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0639-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.