Levothyroxine Sodium Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Levothyroxine Sodium tablets that may have been mislabeled as Isoniazid due to a labeling error.
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 Levothyroxine Sodium, Tablet, 137 mcg (NDC 00527163801) due to a potential labeling mixup. The recalled product, which consists of 100 tablets, may have been mislabeled as Isoniazid, Tablet, 300 mg (NDC 00555007102). The specific pedigree for the recalled Levothyroxine is AD60272_76 with an expiration date of 5/22/2014, while the mislabeled Isoniazid pedigree is AD60272_70 with the same expiration date.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the product might cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Levothyroxine Sodium tablets with the specified NDC and pedigree. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 137 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527163801.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- 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
- 137 mcg has the following codes: Pedigree: AD60272_76
- 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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