FDA Approvals & Recalls — hosted on Cloudflare Workers (HTTP + npm stdio)

What is FDA Approvals & Recalls?

FDA Approvals & Recalls is a hosted MCP server that provides tools to search FDA drug approvals, drug labels, recall events, FAERS adverse-event reports, 510(k) device clearances, and active drug-shortage lists via openFDA and Drugs@FDA. It is designed for pharma research, clinical decision support, and regulatory LLMs.

How to use FDA Approvals & Recalls?

Point any MCP-aware client (Cursor, Claude Desktop, or a custom agent) at the hosted HTTP endpoint with Bearer-token authentication. Use npx -y mcp-remote with the endpoint URL and your API key, or install the npm launcher @insnapsprakhar/fda-approvals-mcp. Configuration examples for Cursor and Claude Desktop are provided in the README.

Key features of FDA Approvals & Recalls

• Search FDA drug approvals by sponsor, brand, generic, or date.
• Retrieve FDA-approved drug labels (indications, dosage, contraindications).
• Query recall events by Class I/II/III classification and date.
• Aggregate FAERS adverse-event reports with safetyreport deduplication.
• Search 510(k) medical-device clearances by applicant or query.
• Monitor current FDA-tracked drug-shortage list.

Use cases of FDA Approvals & Recalls

• Pharma research and drug development pipeline analysis.
• Clinical decision support with up-to-date labeling and safety data.
• Regulatory monitoring of recalls and adverse events for LLM agents.
• Medical-device clearance tracking for compliance teams.
• Drug shortage monitoring for supply-chain management.

FAQ from FDA Approvals & Recalls

What is the pricing for FDA Approvals & Recalls?

Free tier: 100 calls per month per IP. Paid tiers: Solo ($9/mo, 2,000 calls), Team ($29/mo, 10,000 calls, 5 team seats), Pro ($79/mo, 50,000 calls, 25 seats). Billed via Dodo Payments; cancel anytime.

How do I get an API key for FDA Approvals & Recalls?

Visit the upgrade URL, complete Dodo Payments checkout, then copy the key from the welcome page (shown only once). Free anonymous callers do not need a key up to 100 calls per month per IP.

What data sources does FDA Approvals & Recalls use