Lightning ROD capsules recalled for undeclared sildenafil analogue
Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, an unapproved new drug.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Chang Kwung Products is recalling Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles. The recall involves 3,720 capsules distributed nationwide. No lot codes are printed on the product.
The recall was initiated because FDA analysis found the product contains an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction. Consequently, the product is considered an unapproved new drug marketed without an approved NDA/ANDA.
Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
- Manufacturer
- Chang Kwung Products
- Category
- Drug — Unapproved New Drug
- Affected units
- 3,720
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- No lot codes are printed on the product
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Chang Kwung Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Chang Kwung Products
See all →- CriticalLightning ROD capsules recalled for undeclared sildenafil analogue
FDA (Drugs) · 2013-08-14
Same hazard · undeclared ingredient
See all →- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- ModerateDietary supplement Ocular Plus recalled for undeclared Yellow #5
FDA (Food) · 2026-07-08
- ModerateDietary Supplement Vista MAX Recalled for Undeclared Yellow #5 Allergen
FDA (Food) · 2026-07-08
- ModerateEl David Gelee Bonbons Recalled for Undeclared Color Additives
FDA (Food) · 2026-07-01
- HighAdndale magnesium glycinate gummies contain undeclared melatonin in three lots
FDA (Food) · 2026-06-24