Prescription Levothyroxine Sodium Tablets Recalled Due to Sub-Potency
Alvogen is recalling 21,276 bottles of Levothyroxine Sodium Tablets (Lot HE02221, expiration 05/2023) distributed nationwide and in Puerto Rico due to sub-potency.
What this means for you
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: FDA Class II recall with no reported illnesses or injuries. Sub-potency represents a pharmaceutical quality issue where tablets failed assay specifications without confirmed patient harm.
Plain-English summary
Alvogen, Inc. is recalling Levothyroxine Sodium Tablets, USP 112 mcg. Lot HE02221 (expiration date 05/2023), consisting of 21,276 bottles, was distributed nationwide and in Puerto Rico.
The tablets were recalled due to sub-potency. During testing at the 24-month interval, the tablets were found to be out of specification for assay, meaning they did not contain the required amount of active ingredient.
Patients taking the affected lot should contact their healthcare provider or pharmacist. Do not stop taking your medication without medical guidance. Your healthcare provider can advise on the appropriate course of action based on your individual situation.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Alvogen, Inc
- Hazard
- Affected units
- 21,276
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 (2)
- Lot # HE02221
- Exp. 05/2023
UPCs (12)
- 0347781649906
- 0347781671907
- 0347781643904
- 0347781657901
- 0347781640903
- 0347781651909
- 0347781662905
- 0347781665906
- 0347781646905
- 0347781654900
- 0347781728908
- 0347781659905
Distribution
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