The Recall Desk
ModerateFDA (Drugs)·D-592-2014·Announced 2014-01-22

Aidapak Recalls Trazodone Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Dexamethasone, Docusate Sodium, or Guanfacine.

What this means for you

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 (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets (NDC 50111043301) due to a labeling mixup. The recalled product may be potentially mislabeled as Dexamethasone 1 mg tablets, Docusate Sodium 250 mg capsules, or Guanfacine HCl 1 mg tablets.

The affected Trazodone tablets were repacked and distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are associated with the recall, including Pedigree AD37088_4 (EXP 5/9/2014), AD54562_1 (EXP 5/20/2014), and AD39611_4 (EXP 5/14/2014).

Consumers should check their medication packaging for the NDC 50111043301 and the specific pedigree codes listed in the recall notice. If the medication matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.

The recalled product

Product
traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043301
Affected units
400

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 (8)

  • traZODone HCl
  • Tablet
  • 50 mg has the following codes Pedigree: AD37088_4
  • EXP: 5/9/2014
  • Pedigree: AD54562_1
  • EXP: 5/20/2014
  • Pedigree: AD39611_4
  • EXP: 5/14/2014.

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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