The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-547-2014·Announced 2014-01-22

FDA Recalls Mislabeled Melatonin Tablets Distributed by Aidapak Services

Aidapak Services is recalling 1 mg melatonin tablets that may be mislabeled as cranberry extract or glycopyrrolate. The FDA classifies this as a Class II recall.

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 mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.

Plain-English summary

Aidapak Services, LLC is recalling 200-count bottles of 1 mg melatonin tablets (NDC 35046000391) due to a labeling error. The source text indicates that these melatonin tablets may be potentially mislabeled as either Cranberry Extract/Vitamin C capsules (450 mg/125 mg, NDC 31604014271) or Glycopyrrolate tablets (2 mg, NDC 00603318121).

The affected melatonin tablets have specific pedigree and expiration codes: Pedigree W002695 with an expiration date of 6/5/2014, and Pedigree W003317 with an expiration date of 6/18/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

The FDA has classified this recall as Class II, which means the error may cause temporary or medically reversible health consequences. Consumers who have these products should check their labels and contact their pharmacist or the recalling firm for instructions on how to return the product.

The recalled product

Product
MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000391
Manufacturer
Aidapak Services, LLC
Category
Drug — Over-the-Counter
Hazard
Affected units
200

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 (5)

  • MELATONIN Tablet
  • 1 mg has the following codes Pedigree: W002695
  • EXP: 6/5/2014
  • Pedigree: W003317
  • EXP: 6/18/2014.

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 →

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