Levothyroxine Sodium Tablets — Class II drug recall D-0353-2023
Terminated recall by Alvogen, Inc, reported 2023-03-08, distributed nationwide. Sub-Potent Drug: Out of specification for assay at the 24 month interval.
| Recall number | D-0353-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alvogen, Inc, Morristown, NJ, United States |
| Recall initiated | 2023-02-06 |
| Classified | 2023-02-24 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 21,276 bottles |
| Reason classes | potency, specification failure |
| NDC | 47781-0654-90 |
| Lot numbers | HE02221 |
| Expiration dates | 2023-05 |
Product
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
Reason for recall
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0353-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.