Imperial Extreme 2000 Capsules Recalled for Unapproved Active Ingredients
S & B Story LLC is recalling Imperial Extreme 2000 Capsules because FDA analysis found unapproved ingredients tadalafil and sildenafil.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the presence of undeclared potent prescription drugs (tadalafil/sildenafil) in a supplement marketed without approval represents a significant health risk consistent with the Severe classification for Class II recalls involving significant hazards.
Plain-English summary
S & B Story LLC is voluntarily recalling Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards. The product was distributed nationwide by S&B Shopper LLC in Little Ferry, NJ, under UPC 7 18122 04073 5. The recall covers all lots and expiration dates.
The FDA is classifying this as a Class II recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis confirmed the presence of tadalafil and sildenafil, which are active pharmaceutical ingredients not declared on the product label.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund. The presence of undeclared prescription drug ingredients poses a risk of adverse health effects, particularly for individuals taking other medications or with specific medical conditions.
The recalled product
- Product
- Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
- Manufacturer
- S & B Story LLC
- Category
- Drug — Dietary Supplement
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)
- all lots and expirys
Distribution
Distributed nationwide across the United States.
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