CLASS I Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
Lightning ROD capsules, 550 mg/capsule recalled by Chang Kwung Products
Chang Kwung Products is recalling Lightning ROD capsules, 550 mg/capsule, distributed nationwide in the US. The recall was initiated on 6 May 2013 and the FDA has classified it as Class I.
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-834-2013
- FDA event ID
- 49085
- Recalling firm
- Chang Kwung Products, Woodland Hills, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 May 2013
- FDA classified
- 2 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 6 May 2013 | Recall initiated by company | |
| 2 Aug 2013 | Classified by FDA | +88 days |
| 14 Aug 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Product as listed by the FDA
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Which lots are affected?
No lot codes are printed on the product
Where was it sold?
Nationwide
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
1 other product · FDA event 49085This product is part of a recall event; the main page for the event is Lightning ROD capsules, 500 mg/capsule recalled by Chang Kwung Products.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Lightning ROD capsules, 500 mg/capsule recalled by Chang Kwung Products | Chang Kwung Products | Labeling Errors | Nationwide |
More recalls from Chang Kwung Products
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lightning ROD capsules, 500 mg/capsule recalled by Chang Kwung Products | Chang Kwung Products | Labeling Errors | Nationwide |
Other Lightning Rod recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lightning ROD capsules, 500 mg/capsule recalled by Chang Kwung Products | Chang Kwung Products | Labeling Errors | Nationwide |