Ethambutol Hydrochloride Tablets — Class II drug recall D-242-2013
Terminated recall by West-ward Pharmaceutical Corp., reported 2013-04-10, distributed nationwide. Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
| Recall number | D-242-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-04-03 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2013-12-18 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 61748-0011-01 |
| Lot numbers | 07/14, 68028A |
Product
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
Reason for recall
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
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-242-2013. 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.