SUSTANGO supplement capsules recalled for undisclosed tadalafil content
SUSTANGO capsules contain the undisclosed pharmaceutical ingredient tadalafil and were marketed without FDA approval. Approximately 750 cartons were distributed nationwide via Amazon.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls establish a minimum severity score of 4 (Severe). No deaths or serious injuries have been reported.
Plain-English summary
Ultra Supplement LLC is recalling SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, which were distributed nationwide in the United States via Amazon Marketplace. The product is packaged in 10-count blisters per carton, with approximately 750 cartons affected. The recalled lot is DAP272109 with an expiration date of 4/1/2026.
The FDA determined the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Analytical testing revealed the presence of tadalafil, a prescription pharmaceutical ingredient, which was not disclosed on the product label or packaging.
Consumers who purchased this product should stop using it immediately and dispose of it safely. The undisclosed presence of a prescription medication poses potential health risks and may cause dangerous interactions with certain other medications.
Anyone who has consumed this product and has concerns should consult a healthcare provider.
The recalled product
- Product
- SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
- Manufacturer
- Ultra Supplement LLC
- Affected units
- 750
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 DAP272109
- Exp: 4/1/2026
Distribution
Distributed nationwide across the United States.
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