Changeflow GovPing Pharma & Drug Safety Class I Drug Recall D-0388-2026 by ANTHONY TRINH
Urgent Enforcement Added Final

Class I Drug Recall D-0388-2026 by ANTHONY TRINH

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Filed March 13th, 2026
Detected March 27th, 2026
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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

  1. Consumers should stop using SILINTAN 25 pills and consult a healthcare professional.
  2. Manufacturers should review product formulations for undeclared ingredients.
  3. Ensure compliance with NDA/ANDA requirements for all marketed drugs.

Source document (simplified)

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"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-03-18",
"results": {
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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"
}
]
}

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 13th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0388-2026

Who this affects

Applies to
Drug manufacturers Consumers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Labeling Product Safety
Threshold
Class I drug recall
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Consumer Protection

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