Teva Pharmaceuticals USA recalls Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North
Teva Pharmaceuticals recalls 12.5mg Clozapine orally disintegrating tablets due to failed disintegration test. Rx-only medication with specific lot number and expiration date.
Lower-risk recall
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
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What happened, in plain English
Teva Pharmaceuticals is recalling 12.5 mg Clozapine orally disintegrating tablets that failed stability testing. This could mean the tablets don't dissolve properly in the mouth, potentially affecting medication effectiveness. Read more at govinfonow.com/recall/39556-teva-clozapine-tablets-recall-failed-disintegration-test.
Source Summary by GovInfoNow · govinfonow.com/recall/39556-teva-clozapine-tablets-recall-failed-disintegration-test · Updated October 6, 2026 · FDA enforcement record: FDA #D-0001-2019
Cite this page
“Teva Clozapine Tablets Recall: Failed Disintegration Test.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39556-teva-clozapine-tablets-recall-failed-disintegration-test. Based on FDA recall #D-0001-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2019%22&limit=1).
Why it’s dangerous
The tablets failed disintegration testing during routine stability checks. This means they might not dissolve properly in the mouth, which could lead to improper medication delivery. However, this is a quality control issue rather than a safety hazard.
Who’s affected
Prescription medication users who have the specific 12.5 mg Clozapine orally disintegrating tablets with lot number 34034024B. Patients on maintenance treatment for conditions like schizophrenia may be most affected.
How to tell if you have this one
Look for yellow, round, flat-faced tablets with a beveled edge and '13' debossed on one side. The specific lot number 34034024B with expiration date 02/20 is affected.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Medication Details
Verify if your Clozapine tablets have the lot number 34034024B and expiration date 02/20.
Questions people ask
Is this recall dangerous?
No, this is a quality control issue where the tablets failed disintegration testing. It does not pose a safety risk but may affect medication effectiveness.
How do I know if I have the recalled product?
Look for yellow, round, flat-faced tablets with a beveled edge and '13' debossed on one side. The specific lot number 34034024B with expiration date 02/20 is affected.
What should I do if I have the recalled product?
Check if your Clozapine tablets have the lot number 34034024B and expiration date 02/20. If so, contact your doctor or pharmacist for guidance.
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0001-2019 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0001-2019 from Teva Pharmaceuticals. 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-0001-2019 (September 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0001-2019 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.