The Recall Desk
ModerateFDA (Drugs)·D-988-2014·Announced 2014-01-29

Aidapak Recalls Oxybutynin Chloride Tablets Due to Labeling Errors

Aidapak Services, LLC is recalling Oxybutynin Chloride 5 mg tablets because they may have been mislabeled as other prescription drugs.

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 illnesses or injuries, which aligns with the criteria for a Moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Oxybutynin Chloride, Tablet, 5 mg (NDC 00603497521) due to a labeling error. The recalled tablets may have been mislabeled as Flecainide Acetate 100 mg, Sodium Chloride 1 gm, or Varenicline 0.5 mg.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific pedigree codes and expiration dates for the affected Oxybutynin Chloride tablets are AD52778_61 (EXP: 5/20/2014), W003898 (EXP: 6/27/2014), and AD22616_4 (EXP: 5/2/2014).

Consumers should check their medication for these specific codes and expiration dates. If the medication matches the recalled description, they should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the product.

The recalled product

Product
OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.
Affected units
299

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)

  • OXYBUTYNIN CHLORIDE
  • Tablet
  • 5 mg has the following codes: Pedigree: AD52778_61
  • EXP: 5/20/2014
  • Pedigree: W003898
  • EXP: 6/27/2014
  • Pedigree: AD22616_4
  • EXP: 5/2/2014.

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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