Carbidopa/Levodopa Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Carbidopa/Levodopa tablets that may have been mislabeled as Digoxin. Patients should verify their medication labels.
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 'Moderate' severity criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Carbidopa/Levodopa, Tablet, 25 mg/250 mg, NDC 00093029401. The recall is due to a potential label mixup where the medication may have been mislabeled as Digoxin, Tablet, 0.125 mg, NDC 00115981101. The affected product has the pedigree AD46426_28 and an expiration date of 5/15/2014.
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.
Consumers and healthcare providers should check their medication labels to ensure they are taking the correct drug. If a patient has received medication with the incorrect label, they should contact their pharmacist or physician for guidance.
The recalled product
- Product
- CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093029401.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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)
- CARBIDOPA/LEVODOPA
- Tablet
- 25 mg/250 mg has the following codes: Pedigree: AD46426_28
- EXP: 5/15/2014.
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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