Agency classClass IIOur severity:Moderate FDA (Drugs)·D-553-2014·Announced 2014-01-22

Aidapak Recalls Omega-3 Fatty Acid Capsules Due to Labeling Error

Aidapak Services, LLC is recalling Omega-3 Fatty Acid Capsules, 1000 mg, because they may be mislabeled as other medications. The affected products were distributed in Arizona, California, Oregon, and Washington.

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 due to a labeling error (label mixup) that could lead to incorrect medication use, which fits the rubric for moderate severity involving minor labeling errors or low-risk contamination without reported serious injury.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling 36,840 capsules of OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, NDC 40985022921. The recall was initiated because the product may be potentially mislabeled as other drugs, including Pyridoxine HCL, Cholecalciferol, and Docusate Sodium.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers specific pedigree codes and expiration dates ranging from May 1, 2014, to June 26, 2014. Consumers should check their medication labels and stop using the product if it matches the recalled description.

The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences. Consumers should consult their healthcare provider if they have questions about the recalled product.

The recalled product

Product: OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Supplement
Hazard: mis-labeling
Affected units: 36,840

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 (20)

OMEGA-3 FATTY ACID Capsule
1000 mg has the following codes Pedigree: AD21846_1
EXP: 5/1/2014
Pedigree: AD30028_4
EXP: 5/8/2014
Pedigree: W003015
EXP: 6/12/2014
Pedigree: W003710
EXP: 6/26/2014
Pedigree: W003711
Pedigree: AD46257_1
EXP: 5/15/2014
Pedigree: W002965
EXP: 6/10/2014
Pedigree: W003312
EXP: 6/18/2014
Pedigree: AD30028_1
Pedigree: AD46257_4
Pedigree: AD32742_1
Pedigree: AD60240_1

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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Same hazard · mis labeling