Macleods Pharmaceuticals Limited recalls Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ,
Macleods Pharmaceuticals recalls 5mg Olanzapine tablets due to impurities that could pose health risks. Affected products have specific lot numbers and expiration dates. Consumers should contact the manufacturer for details.
Lower-risk recall
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
What happened, in plain English
Macleods Pharmaceuticals is recalling 5mg Olanzapine tablets because they contain impurities that may cause health risks. This recall affects specific batches produced in India with a particular expiration date. The issue does not involve immediate danger but requires action to ensure safety. Read more at govinfonow.com/recall/1287573-macleods-olanzapine-tablets-5mg-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/1287573-macleods-olanzapine-tablets-5mg-recall-impurities-may-cause-harm · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #D-0867-2026
Cite this page
“Macleods Olanzapine Tablets 5mg Recall: Impurities May Cause Harm.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1287573-macleods-olanzapine-tablets-5mg-recall-impurities-may-cause-harm. Based on FDA recall #D-0867-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0867-2026%22&limit=1).
Why it’s dangerous
The tablets contain organic and unspecified impurities above acceptable levels. These impurities could potentially cause health issues, though the exact risk is not specified in the recall notice.
Who’s affected
Prescription patients who received the recalled Olanzapine tablets from Macleods Pharmaceuticals. Those most at risk are individuals with specific medical conditions requiring these medications.
How to tell if you have this one
Check for the product name 'Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only'. The lot number is BOB22321A and the expiration date is July 31, 2027. This product was manufactured in India and distributed by Macleods Pharma USA, Inc.
- Brand
Macleods- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number BOB22321A and expiration date of July 31, 2027 on the product label.
Questions people ask
Is this product safe to use?
The recall states there are impurities above specifications, but the exact health risk is not detailed. Consumers should follow the manufacturer's instructions.
How can I confirm if my product is affected?
Check for the lot number BOB22321A and expiration date of July 31, 2027 on the product label.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Macleods Pharmaceuticals for further instructions.
Contact Macleods
We’ve drafted a message you can send Macleods to request your refund or repair — edit it as you like.
Subject: Recall D-0867-2026 — Macleods Macleods Hello, I own a Macleods that is covered by recall D-0867-2026 from Macleods. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0867-2026 (August 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0867-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.