Teva Pharmaceuticals USA recalls Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High
Teva Pharmaceuticals USA recalls 120-count Omega-3 capsules due to unapproved manufacturing materials. This may pose safety risks if taken without regulatory approval. Consumers should contact Teva for details.
Recall notice
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling 120-count Omega- 3 capsules because the manufacturing materials used were not approved by regulators. This could lead to safety risks if taken without proper regulatory oversight. Read more at govinfonow.com/recall/40361-teva-omega-3-capsules-recall-unapproved-api-material-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40361-teva-omega-3-capsules-recall-unapproved-api-material-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1074-2018
Cite this page
“Teva Omega-3 Capsules Recall: Unapproved API Material Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40361-teva-omega-3-capsules-recall-unapproved-api-material-risk. Based on FDA recall #D-1074-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1074-2018%22&limit=1).
Why it’s dangerous
The capsules were made using an API material that wasn't approved by regulatory authorities before being released. This could mean the product doesn't meet safety standards and might cause health issues if taken without proper oversight.
Who’s affected
People who have the 120-count Omega-3 capsules with NDC 0093-5401-89 and lot number 150001420A are affected. Those who take prescription omega-3 supplements are most at risk.
How to tell if you have this one
Check for the 120-count bottle labeled 'Omega-3-Acid Ethyl Esters Capsules USP, 1 gram*'. Look for the lot number 150001420A and expiration date 2/2019 on the packaging.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Product Details
Verify the product has NDC 0093-5401-89 and lot number 150001420A.
Questions people ask
Why is this product being recalled?
The capsules were made using an API material that wasn't approved by regulatory authorities before being released.
How can I tell if I have the recalled product?
Check for the 120-count bottle labeled 'Omega-3-Acid Ethyl Esters Capsules USP, 1 gram*' with lot number 150001420A and expiration date 2/2019.
What should I do if I have the recalled product?
The recall record does not specify a remedy, so contact Teva Pharmaceuticals USA for further instructions.
Contact Teva Pharmaceuticals USA
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-1074-2018 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-1074-2018 from Teva Pharmaceuticals USA. 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-1074-2018 (July 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1074-2018 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.