Agency classClass IIOur severity:Moderate FDA (Drugs)·D-874-2014·Announced 2014-01-29

Omega-3 Acid Ethyl Esters Capsules Recalled for Potential Label Mixup

Aidapak Services, LLC is recalling Omega-3 Acid Ethyl Esters capsules due to a potential label mixup with other medications. The repacked drugs were distributed in four western states.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 and involves a labeling error (label mixup) with no reported illnesses or injuries, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling 1,439 capsules of OMEGA-3-ACID ETHYL ESTERS, 1000 mg, Over The Counter, NDC 00173078302. The recall is due to a labeling issue where the product may have been mislabeled as one of three other distinct drugs: SEVELAMER CARBONATE, Tablet, 800 mg; hydrOXYzine PAMOATE, Capsule, 100 mg; or PROPRANOLOL HCL, Tablet, 10 mg.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the number of affected units or report any illnesses or injuries associated with this recall.

Consumers should check their medication labels for the specific NDC and pedigree codes listed in the recall notice. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00173078302.
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-The-Counter Medication
Hazard: mis-labeling
Affected units: 1,439

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 (16)

OMEGA-3-ACID ETHYL ESTERS
Capsule
1000 mg has the following codes: Pedigree: AD46265_43
EXP: 5/15/2014
Pedigree: W002736
EXP: 6/6/2014
Pedigree: W003243
EXP: 6/17/2014
Pedigree: W003692
EXP: 6/26/2014
Pedigree: AD32757_40
EXP: 5/14/2014
Pedigree: W003011
EXP: 6/12/2014
Pedigree: W003333
EXP: 6/19/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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Same hazard · mis labeling