Aurobindo Pharma USA Inc. recalls Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279
Aurobindo Pharma USA recalls 100mg Clozapine tablets (500-count) after consumer complaints of 50mg tablets being present in some bottles.
Lower-risk recall
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Contact the company & request your remedy
What happened, in plain English
Aurobindo Pharma is recalling 100mg Clozapine tablets (500-count bottles) because some bottles contain 50mg tablets instead of the intended 100mg tablets. This could lead to incorrect dosing if taken without noticing the difference. Read more at govinfonow.com/recall/37050-aurobindo-pharma-recalls-clozapine-100mg-tablets-due-to-foreign-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/37050-aurobindo-pharma-recalls-clozapine-100mg-tablets-due-to-foreign-tablets · Updated October 5, 2026 · FDA enforcement record: FDA #D-1370-2020
Cite this page
“Aurobindo Pharma recalls Clozapine 100mg tablets due to foreign tablets.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37050-aurobindo-pharma-recalls-clozapine-100mg-tablets-due-to-foreign-tablets. Based on FDA recall #D-1370-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1370-2020%22&limit=1).
Why it’s dangerous
The recall is due to consumer complaints that some 100mg Clozapine tablets contain 50mg tablets. This could cause patients to take less medication than prescribed if they don't notice the smaller tablets.
Who’s affected
Patients prescribed Clozapine who have the 500-count bottles with NDC 65862-846-05 and lot number CZSC20003-A are affected. Those taking the medication without checking the tablet strength may be at risk of incorrect dosing.
How to tell if you have this one
Check for the NDC code 65862-846-05 and lot number CZSC20003-A on the bottle. The product is a 500-count bottle of Clozapine Tablets USP 100mg, Rx only, distributed by Aurobindo Pharma USA, Inc.
- Brand
Aurobindo Pharma- Category
Drug
What to do — step by step
Check Tablet Strength
Verify that each tablet in the bottle is labeled 100mg, not 50mg.
Questions people ask
Why is this product being recalled?
The recall is due to consumer complaints that some 100mg Clozapine tablets contain 50mg tablets instead of the intended strength.
What should I do if I have this product?
Check the tablet strength in your bottle. If you find 50mg tablets, contact your doctor or pharmacist for guidance.
Is there a specific lot number I should check?
Yes, the affected lot number is CZSC20003-A with NDC 65862-846-05.
Contact Aurobindo Pharma
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1370-2020 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-1370-2020 from Aurobindo Pharma. 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-1370-2020 (June 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1370-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.