CLASS II Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report
Omega-3-Acid Ethyl Esters Capsules USP* recalled
Teva Pharmaceuticals USA is recalling Omega-3-Acid Ethyl Esters Capsules USP*, distributed nationwide in the US. The recall was initiated on 16 Jul 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1074-2018
- FDA event ID
- 80550
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2018
- FDA classified
- 8 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 16 Jul 2018 | Recall initiated by company | |
| 8 Aug 2018 | Classified by FDA | +23 days |
| 15 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Product as listed by the FDA
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
Where it was distributed
Product was distributed throughout the United States
Questions about this recall
Why was it recalled?
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Which lots are affected?
Lot # 150001420A, EXP 2/2019
Where was it sold?
Product was distributed throughout the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Omega-3-acid Ethyl Esters * recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid Ethyl Esters, Capsule, 1000 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |