CLASS II Drug recall · Reported 14 Mar 2018 · FDA Enforcement Report
Vardenafil HCl, USP (trihydrate), 500 GM Part # recalled
Kalchem International is recalling Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, distributed in Texas. The recall was initiated on 19 Feb 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0582-2018
- FDA event ID
- 79304
- Recalling firm
- Kalchem International, Lindsay, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Feb 2018
- FDA classified
- 7 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
Timeline
| 19 Feb 2018 | Recall initiated by company | |
| 7 Mar 2018 | Classified by FDA | +16 days |
| 14 Mar 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
TX
Questions about this recall
Why was it recalled?
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Which lots are affected?
Lot #: 070717-1
Where was it sold?
TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.