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.
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: 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
- Hazard
- undeclared-tadalafil
- unapproved-drug
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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