US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

OMEGA-3 FATTY ACID Capsule

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014; CHOLECALCIFEROL, Capsule, 2000 units, ND

What was recalled

OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-553-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Class II · Moderate risk Ongoing

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Reason Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

The Harvard Drug Group LLC D-0493-2026
Class II · Moderate risk Ongoing

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas

Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

C & A Naturistics D-0024-2025
Class II · Moderate risk Ongoing

DOP Instant Hand Sanitizer

Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Omega & Delta Co., Inc. D-0104-2024
Class II · Moderate risk Ongoing

DOP Instant Hand Sanitizer

Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Omega & Delta Co., Inc. D-0103-2024