Agency classClass IIOur severity:Moderate FDA (Drugs)·D-605-2014·Announced 2014-01-22

FDA Recalls Melatonin Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling 3 mg Melatonin tablets because they may be mislabeled as other medications like Docusate Sodium or Pioglitazone.

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) without reported illnesses or injuries, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling 718 tablets of MELATONIN Tablet, 3 mg (NDC 51991001406) due to a labeling error. The recall is necessary because the melatonin tablets may be potentially mislabeled as other drugs, including Docusate Sodium Capsule, 250 mg, Pioglitazone Tablet, 15 mg, or Coenzyme Q-10 Capsule, 100 mg.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The affected product includes specific pedigree codes and expiration dates ranging from April 30, 2014, to July 1, 2014.

Consumers who have purchased this product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return the medication.

The recalled product

Product: MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991001406
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter
Hazard: mis-labeling
Affected units: 718

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 (14)

MELATONIN
Tablet
3 mg has the following codes Pedigree: AD25452_16
EXP: 5/3/2014
Pedigree: AD28322_7
EXP: 5/6/2014
Pedigree: AD70655_14
EXP: 5/28/2014
Pedigree: W003999
EXP: 7/1/2014
Pedigree: AD32325_7
EXP: 5/9/2014
Pedigree: AD68019_7
EXP: 5/28/2014.

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