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.
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 (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.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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