FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Error
Aidapak Services is recalling Levothyroxine Sodium 112 mcg tablets because they may have been mislabeled as Raltegravir 400 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 moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Levothyroxine Sodium, Tablet, 112 mcg, NDC 00527134601, due to a labeling error. The recalled product may have been mislabeled as Raltegravir, Tablet, 400 mg, NDC 00006022761. The specific pedigree for the recalled Levothyroxine is AD60272_22 with an expiration date of 5/22/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should verify the labeling of their Levothyroxine Sodium 112 mcg tablets. If the product matches the description and pedigree listed above, it should be returned to the pharmacy or discontinued use pending further instructions from a healthcare professional.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134601.
- 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)
- LEVOTHYROXINE SODIUM
- Tablet
- 112 mcg has the following codes: Pedigree: AD60272_22
- EXP: 5/22/2014.
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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