FDA Recalls Silver Bullet Male Enhancement Capsules for Undeclared Active Ingredient
The FDA is recalling Silver Bullet male enhancement capsules because they contain an undeclared active ingredient (Sildenafil) and were marketed without an approved NDA/ANDA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I (explicitly noted in source metadata) and involves an undeclared active ingredient in a drug product, which meets the highest severity threshold per the rubric (FDA Class I recalls receive a critical rating).
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Silver Bullet male enhancement capsules (10 capsules in a blister pack) sold nationwide in the United States. The recall is due to the product containing an undeclared active ingredient—Sildenafil—and was marketed without an approved New Drug Application (NDA) or Approved New Drug Substitution (ANDA).
Consumers who purchased these capsules should stop using them immediately. The manufacturer, Natures Rx, distributed the product across the country under lot #01251ZX1 (expired 11/2022). Affected individuals are advised to contact their healthcare provider if they experience any adverse reactions while using the product.
This action addresses a safety concern stemming from regulatory non-compliance regarding drug formulation disclosure, requiring removal from the market until proper labeling and approval processes are completed.
The recalled product
- Product
- Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.
- Manufacturer
- Natures Rx
- Category
- Drug — Male Enhancement Capsules
- Hazard
- Affected units
- 2,800
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 (2)
- Lot # 01251ZX1
- exp. date 11/2022 UPC: 610877392698
Distribution
Distributed nationwide across the United States.
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