Teva Pharmaceuticals USA recalls Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD,
Teva Pharmaceuticals USA recalls 10mg fluoxetine tablets due to impurities found in stability testing. Affected products may have unsafe levels of lactoside. Contact for return instructions.
Lower-risk recall
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals is recalling fluoxetine tablets (10mg, 30-count) because routine testing found unsafe impurities. This could pose health risks if taken as directed. Read more at govinfonow.com/recall/40890-teva-fluoxetine-tablets-recall-impurities-risk-in-10mg-dose.
Source Summary by GovInfoNow · govinfonow.com/recall/40890-teva-fluoxetine-tablets-recall-impurities-risk-in-10mg-dose · Updated October 7, 2026 · FDA enforcement record: FDA #D-0578-2018
Cite this page
“Teva Fluoxetine Tablets Recall: Impurities Risk in 10mg Dose.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40890-teva-fluoxetine-tablets-recall-impurities-risk-in-10mg-dose. Based on FDA recall #D-0578-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0578-2018%22&limit=1).
Why it’s dangerous
Routine stability testing detected impurities in the tablets that could be harmful if taken. The impurities are not expected to cause serious injury but may affect safety.
Who’s affected
People with prescriptions for fluoxetine tablets from Teva Pharmaceuticals USA. Those taking the medication as directed are most at risk.
How to tell if you have this one
Check for Teva Pharmaceuticals USA's 10mg fluoxetine tablets in 30-count bottles. The product was manufactured in Israel and sold with NDC 0093-7188-56.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the 10mg fluoxetine tablets in 30-count bottles with NDC 0093-7188-56.
Questions people ask
Why is this product being recalled?
Routine stability testing found impurities that may be unsafe. Teva Pharmaceuticals USA is recalling all lots within expiry.
How do I know if I have the recalled product?
Check for Teva Pharmaceuticals USA's 10mg fluoxetine tablets in 30-count bottles with NDC 0093-7188-56.
What should I do if I have the recalled product?
The recall record does not specify a remedy, so contact Teva Pharmaceuticals USA for instructions.
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-0578-2018 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0578-2018 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-0578-2018 (February 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0578-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.