PharmaDB
Use case · Compliance, Inspection & Supplier Risk · FDA Field Alert Feed v.04.2026 · refreshed weekly
Use cases Compliance, Inspection & Supplier Risk FDA Field Alert Feed
Compliance, Inspection & Supplier Risk Buyer view Data · FDA field alert publicationsData · FDA drug shortage list Live

FDA Field Alert Feed

Track every FDA field alert report (FAR) and FDA-issued supply notification. 3,419 events indexed, joined to plant and product, refreshed weekly.

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Example output · recent field alerts and supply-event notifications
3,419 FDA field alerts and supply notifications in the catalog · upstream signal of recall and shortage
n=3,419 field alerts · FDA field alert feed Authoritative

The catalog indexes 3,419 FDA field alerts and supply notifications. Field alert reports are the upstream signal of recall and shortage: a manufacturer files a FAR within 72 hours of identifying a quality issue that may affect distributed product. Roughly 60% of field alerts resolve without a formal recall; the remainder escalate to Class II or Class III recall. The feed surfaces FARs, manufacturing-problem notifications, and increased-demand supply events in a single stream.

  1. 2026-04-28
    Class 2 Medicines Recall
    Sertraline 100mg film-coated tablets · MHRA · EL(26)A/22
    Amarox Limited
  2. 2026-04-22
    Manufacturing Problem
    Acute supply event flagged on the FDA drug-shortage feed · unspecified plant
    Multi-site supply notification
  3. 2026-04-22
    Supply Notification
    Demand-side shortage notification · multi-product · refresh of the shortage list
    Increased demand
  4. 2026-04-22
    Approval Notification
    Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
    Merck Enflonsia clesrovimab
  5. 2025-12-08
    Field Alert Report
    Quality issue identified in distributed sterile product · investigation ongoing
    Multi-site sterile injectable
  6. 2025-11-15
    Field Alert Report
    Particulate matter identified in vial inspection · investigation ongoing
    Multi-site fill-finish
  7. 2025-10-22
    Manufacturing Problem
    Active ingredient supply disruption flagged · downstream products at risk
    Multi-site API supply
  8. 2025-09-30
    Field Alert Report
    Out-of-specification stability result identified post-distribution · investigation
    Multi-site oral solid
Field alerts indexed
3,419
Escalation to recall
~40%
Lead time (median)
~25 days
Catalog refresh
weekly
30 seconds

How it works

molecule losartan origin IN destination BR
01

Subscribe a product or plant list.

Upload products, NDC codes, or supplier plants. PharmaDB resolves to the field-alert taxonomy.

0 HHI 0.42 1
computed · pre-joined · anonymised
02

The AI agent watches the FAR stream.

Every new field alert, manufacturing-problem notification, and supply event is matched against the resolved list weekly.

brief · cited
Lane concentration · structurally concentrated
HHI0.42
Top-3 share71%
Actionqualify second source
03

Save the upstream-signal brief.

Citation-anchored dossier with the alert reason, the projected escalation path, and the historical resolution arc for the same plant or product.

Why a buyer runs it

Recall and shortage, upstream.

Pre-recall signal.

Field alerts publish before formal recalls. The buyer gets the upstream view of quality issues that may escalate to Class II or III.

Supply-event overlay.

FDA drug-shortage feed entries surface in the same stream. Manufacturing-problem and increased-demand signals matter to procurement planning, not just to QA.

Escalation lead time.

Median time from a field alert to a formal recall is roughly twenty-five days across the historical archive. The lead-time chip flags imminent recall risk.

Repeat-FAR pattern.

Plants and products with two or more field alerts in trailing 12 months get a repeat-FAR chip. The pattern is more predictive of systemic CGMP risk than any single alert.

What a real chat looks like

Type a window. The AI agent returns the field-alert feed.

A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.

Field alert feed · trailing 12 months
chat · saved 2 min ago
You
Surface every FDA field alert and supply notification published in the trailing 12 months. Resolve to plant and product. Highlight any drug shortage signals.
F
Running tool pharmagraph_query
compliance_events ⋈ plants · event_type=field_alert · trailing 12 months · 18 supply-relevant events
F
Eighteen supply-relevant field alerts and notifications in the trailing 12 months. Sterile injectables dominate (8 events) with particulate matter and sterility-assurance issues as the recurring root causes. The API supply-disruption event in October 2025 is the highest-severity upstream signal: an API outage propagated to multiple downstream finished-pharma products over the following ten weeks. No supplier on your current watchlist is associated with these events; the closest match is a fill-finish CMO that shares an API source with two of your suppliers.
Recent field alerts · reverse chronological
1 Amarox Sertraline · MHRA Class 2 2026-04-28 · sertraline 100mg film-coated tablets recall
2 Multi-site sterile FAR · particulate 2025-11-15 · particulate matter in vial inspection
3 API supply disruption 2025-10-22 · active-ingredient supply event · downstream risk
+15 more · open in PharmaDB
Cited compliance_events 3,419 indexed plants resolved FDA drug shortage feed joined
Ask a follow-up... ⌘ ↵
Time-to-answer

Manual workflow vs. PharmaDB.

Manual workflow
Excel · email · syndicated reports
  1. 01 Monitor FDA field alert publications Daily polling
  2. 02 Cross-reference with drug-shortage list 1-2 hr
  3. 03 Resolve to plant and product 2-3 hr
  4. 04 Project escalation to recall 2 hr
  5. 05 Compose upstream-signal note 1-2 hr
Total cycle time 1 day per week of events
PharmaDB
The AI agent · one query · cited
One subscription.
Pre-joined warehouse. Field alerts resolved to plant and product, severity classified, escalation lead-time projected from the historical arc. The notification fires as soon as a match is detected.
Total cycle time On publication
Run it across your supplier base

Where field alerts concentrate.

Twelve plants with a field-alert pattern in the catalog · alert reason and downstream recall co-occurrence shown.

Hospira fill-finish (US) US · multi-site
VAI
4 obs · 36 mo → flat
Hikma USA US · multi-site
VAI
3 obs · 36 mo → flat
Sandoz Princeton US · New Jersey
VAI
2 obs · 36 mo → flat
Lupin Baltimore US · Maryland
VAI
2 obs · 36 mo → flat
Mylan Morgantown US · West Virginia
VAI
2 obs · 36 mo → flat
Aurobindo Pharma USA US · multi-site
VAI
2 obs · 36 mo → flat
Fresenius Kabi USA US · multi-site
VAI
3 obs · 36 mo → flat
Amneal Pharmaceuticals USA US · Bridgewater
VAI
2 obs · 36 mo → flat
Sun Pharma Cranbury US · New Jersey
VAI
1 obs · 36 mo → flat
Teva Salt Lake US · Utah
VAI
1 obs · 36 mo → flat
Glenmark Monroe Township US · New Jersey
VAI
1 obs · 36 mo → flat
Cipla Goa IN · Goa
VAI
1 obs · 36 mo → flat
NAI · no action indicated · clean VAI · voluntary action · monitor OAI · official action · deprioritise

The field alert feed is the upstream recall and shortage signal. PharmaDB joins FARs to the plant catalog, overlays the drug-shortage list, and projects escalation lead-time from the historical arc. The view is compliance_events filtered to event_type = 'field_alert'. Refresh cadence is weekly.

FAQ

Frequently asked

What is a field alert report?+

A field alert report (FAR) is a notification a drug manufacturer must file with the FDA within three working days of identifying a quality issue that may affect distributed product. It is the upstream signal: most recalls begin with a field alert. The FAR is non-public at filing; PharmaDB indexes the resulting FDA publications and downstream enforcement events.

What proportion of field alerts escalate to recalls?+

Roughly 40% across the historical archive. The remainder resolve through CAPA and product-quality investigation without distribution-level removal. The escalation rate varies by product class: sterile injectable field alerts escalate at a higher rate than oral solid alerts.

What is the lead time from field alert to recall?+

Median is roughly twenty-five days across the catalog. The chip flags imminent recall risk where the lead-time signal is short. Useful for supply planning when a downstream product is dependent on the cited plant.

Are non-FDA field alert equivalents covered?+

MHRA medicines recalls, EMA quality defect notifications, Health Canada signals, and TGA quality alerts are all tracked. The cross-regulator field-alert view surfaces in a combined feed at the buyer's choice.

How fresh is the data?+

Field alerts publish on the FDA enforcement feed weekly, with a typical seven-day lag from filing. PharmaDB pulls each refresh and surfaces new events within days. The catalog row carries the filing date and the publication date.

Does the feed cover drug-shortage signals?+

Yes. The FDA drug-shortage list and the EMA shortage feed are joined to the field-alert stream. Manufacturing-problem and increased-demand notifications surface alongside the QA-driven FARs because both matter to procurement planning.

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