Levoxyl — Class II drug recall D-428-2013
Terminated recall by King Legacy, a wholly owned subsidiary of Pfizer, reported 2013-05-29, distributed nationwide. Subpotent Drug: The products were below specification for potency at the expiry stability point.
| Recall number | D-428-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | King Legacy, a wholly owned subsidiary of Pfizer, Bristol, TN, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-05-20 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2016-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 77,272 bottles |
| Reason classes | potency, specification failure |
| NDC | 60793-0850, 60793-0850-01, 60793-0850-10, 60793-0851, 60793-0851-01, 60793-0851-10, 60793-0852, 60793-0852-01, 60793-0852-10, 60793-0853, 60793-0853-01, 60793-0853-10, 60793-0854, 60793-0854-01, 60793-0854-10, 60793-0855, 60793-0855-01, 60793-0855-10, 60793-0856, 60793-0856-01, 60793-0856-10, 60793-0857, 60793-0857-01, 60793-0857-10, 60793-0858 and 8 more |
Product
Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Reason for recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
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-428-2013. 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.