Ethambutol Hydrochloride Tablets USP — Class III drug recall D-346-2014
Terminated recall by Lupin Pharmaceuticals Inc., reported 2013-12-18, distributed nationwide. Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification re
| Recall number | D-346-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2013-02-22 |
| Classified | 2013-12-12 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2013-12-30 |
| Distributed | Nationwide (US) |
| Quantity | 4,896 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00368180281016 |
| NDC | 68180-0280, 68180-0280-01, 68180-0281, 68180-0281-01, 68180-0281-02, 68180-0281-11 |
| Lot numbers | 05/14, 3122856 |
Product
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
Reason for recall
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
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-346-2014. 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.