Vardenafil HCl — Class II drug recall D-0582-2018
Terminated recall by Kalchem International, Inc., reported 2018-03-14, distributed in TX. cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiratio
| Recall number | D-0582-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kalchem International, Inc., Lindsay, OK, United States |
| Recall initiated | 2018-02-19 |
| Classified | 2018-03-07 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2020-09-15 |
| Distributed | TX |
| Quantity | 500 gram |
| Reason classes | cgmp, specification failure |
| NDC | 60592-0330-05 |
| Lot numbers | 070717-1 |
| Model numbers | 330-05 |
Product
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
Reason for recall
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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-0582-2018. 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.