Losartan Potassium Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Losartan Potassium 50 mg tablets because they may have been mislabeled as Atorvastatin Calcium 80 mg.
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 injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Losartan Potassium, Tablet, 50 mg (NDC 00781570192) due to a labeling mixup. The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington.
The recall is being conducted because the Losartan Potassium tablets may have been mislabeled as Atorvastatin Calcium, Tablet, 80 mg (NDC 60505267109). The specific pedigree for the potentially mislabeled product is AD21965_4, with an expiration date of 5/1/2014.
Patients and healthcare providers should verify the labeling of their medication. If the label indicates Atorvastatin Calcium 80 mg but the patient was prescribed Losartan Potassium 50 mg, they should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- LOSARTAN POTASSIUM, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781570192.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 90
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)
- LOSARTAN POTASSIUM
- Tablet
- 50 mg has the following codes: Pedigree: AD21965_10
- EXP: 5/1/2014.
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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