Teva Recalls Omega-3 Capsules Due to Unapproved Manufacturing Material
Teva Pharmaceuticals is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules because an API material used in manufacturing did not receive regulatory approval prior to release.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue regarding unapproved API material, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules USP, 1 gram, 120-count. The product is prescription-only and was distributed throughout the United States. The specific lot affected is # 150001420A with an expiration date of 2/2019.
The recall was initiated because the API material used in the manufacturing of the product did not receive regulatory approval prior to release. The product was manufactured by Banner Pharmacaps, Inc. in High Point, NC, for Teva Pharmaceuticals USA Inc. in North Wales, PA.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 150001420A
- EXP 2/2019
Distribution
Distribution scope not specified by the agency.
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