The Recall Desk
ModerateFDA (Drugs)·D-987-2014·Announced 2014-01-29

Oxybutynin Chloride Tablets Recalled for Potential Labeling Error

Aidapak Services is recalling Oxybutynin Chloride tablets that may be mislabeled as Pimozide. The error could lead to patients receiving the wrong medication.

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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The source text describes a labeling mixup without reported injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Oxybutynin Chloride tablets, 2.5 mg, NDC 00603497521. The recall is due to a labeling error where the product may have been mislabeled as Pimozide tablets, 1 mg, NDC 57844018701. The affected Oxybutynin Chloride tablets have the pedigree AD73525_64 and an expiration date of 5/30/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the number of units affected or report any illnesses or injuries associated with this labeling error.

Patients and healthcare providers should check their medication labels. If the label indicates Pimozide but the patient was prescribed Oxybutynin Chloride, or vice versa, they should contact their healthcare provider or pharmacist for guidance before taking the medication.

The recalled product

Product
OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521
Affected units
199

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 (4)

  • OXYBUTYNIN CHLORIDE
  • Tablet
  • 2.5 mg (1/2 of 5 mg) has the following codes: Pedigree: AD73525_64
  • EXP: 5/30/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 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 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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