Levothyroxine Sodium Tablets — Class II drug recall D-1084-2014
Terminated recall by Mylan Pharmaceuticals Inc., reported 2014-02-19, distributed nationwide. Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were bel
| Recall number | D-1084-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2014-01-14 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2015-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 138,970 bottles |
| Reason classes | potency, specification failure |
| NDC | 00378-1819-01 |
| Lot numbers | 03/14, 04/14, 3037531, 3038284 |
Product
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
Reason for recall
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
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-1084-2014. 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.