Teva Ethambutol Hydrochloride Tablets — Class II drug recall D-1092-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-03-12, distributed nationwide. CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: th
| Recall number | D-1092-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2014-01-24 |
| Classified | 2014-02-28 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 10,405 tablets |
| Reason classes | cgmp, unapproved product |
| NDC | 00555-0923-02 |
| Lot numbers | 01/16, 34013698A, 34013699A, 34013700A, 34013756A |
Product
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
Reason for recall
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
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-1092-2014. 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.