Class I Drug Recall D-0388-2026 by ANTHONY TRINH
Summary
The FDA has initiated a Class I drug recall (D-0388-2026) for SILINTAN 25 pills, voluntarily initiated by ANTHONY TRINH, 123Herbals LLC. The recall is due to the presence of undeclared meloxicam, a potentially dangerous ingredient.
What changed
The Food and Drug Administration (FDA) has announced a Class I recall for SILINTAN 25 pills, identified by recall number D-0388-2026. The recall was initiated voluntarily by ANTHONY TRINH, 123Herbals LLC, due to the product being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis revealed the presence of undeclared meloxicam, a significant safety concern.
This recall impacts nationwide distribution within the USA. Consumers who have purchased SILINTAN 25 pills should immediately stop using the product and consult with a healthcare professional. Drug manufacturers and distributors should review their product lines for undeclared ingredients and ensure compliance with NDA/ANDA requirements. The recall is ongoing, and further information can be found via the FDA's enforcement database.
What to do next
- Consumers should stop using SILINTAN 25 pills and consult a healthcare professional.
- Manufacturers should review product formulations for undeclared ingredients.
- Ensure compliance with NDA/ANDA requirements for all marketed drugs.
Source document (simplified)
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"last_updated": "2026-03-18",
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"results": [
{
"status": "Ongoing",
"city": "Rosemead",
"state": "CA",
"country": "United States",
"classification": "Class I",
"openfda": {
},
"product_type": "Drugs",
"event_id": "98258",
"recalling_firm": "ANTHONY TRINH, 123Herbals LLC",
"address_1": "7214 Berne St",
"address_2": "N/A",
"postal_code": "91770-3844",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Press Release",
"distribution_pattern": "USA nationwide",
"recall_number": "D-0388-2026",
"product_description": "SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China",
"product_quantity": "N/A",
"reason_for_recall": "Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.",
"recall_initiation_date": "20251020",
"center_classification_date": "20260313",
"report_date": "20260311",
"code_info": "All lots within expiry"
}
]
}
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