Agency classClass IIOur severity:Moderate FDA (Drugs)·D-497-2014·Announced 2014-01-22

FDA Recalls Melatonin Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling 3 mg melatonin tablets distributed in four western states because they may be mislabeled as other supplements.

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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a labeling mixup rather than a high-risk pathogen or structural defect, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling 3,710 tablets of 3 mg melatonin (NDC 08770140813) due to a labeling mixup. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

The recall is necessary because the melatonin tablets may be mislabeled as other products, including Vitamin B Complex, Multivitamin/Multimineral/Lutein, Lactase Enzyme, or Glucosamine/Chondroitin DS. The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers who have purchased these specific melatonin tablets should stop using them and return them to the place of purchase or contact the recalling firm for a refund. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Supplement
Hazard: mis-labeling
Affected units: 3,710

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)

MELATONIN
Tablet
3 mg has the following codes Pedigree: AD46257_56
EXP: 5/15/2014
Pedigree: W003022
EXP: 6/12/2014
Pedigree: W003723
EXP: 6/26/2014
Pedigree: AD21846_34
EXP: 5/1/2014
Pedigree: AD30028_28
EXP: 5/7/2014
Pedigree: AD60240_39
EXP: 5/22/2014
Pedigree: AD73521_31
EXP: 5/30/2014
Pedigree: W002701
EXP: 6/5/2014
Pedigree: W003320
EXP: 6/19/2014.

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