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Abbott10-K: Quality issue

Entered into FDA consent decree following major infant formula recall

What happened

A voluntary recall of infant formula from the Sturgis, Michigan facility led to an FDA consent decree. This significant regulatory action creates intense pressure to overhaul quality management systems (QMS), improve product traceability, and ensure stringent compliance to avoid future shutdowns, fines, and reputational damage.

Source

SEC EDGARFeb 20, 2026

Annual report (Form 10-K)

Abbott 10-K for FY2025

Filing excerpt

in February 2022, Abbott initiated a voluntary recall of certain powder infant formula products manufactured at its facility in Sturgis, Michigan at which time it temporarily stopped manufacturing at the facility.

sec.gov/Archives/edgar/data/1800/000162828026010185/abt-20251231.htmRead the full source

Other signals in this filing (11)

Extracted by Autobound

From the Signal API record
Signal
10-K: Quality issue

What this signalsFilings often name leadership changes, deals and spending plans.

Period
FY2025
Fiscal year end
12/31
Filed
Feb 20, 2026

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The full record

From the Signal API record

Details

CIK
1800
Accession number
0001628280-26-010185
Timeframe
Current year
Filing year
2026
Why it matters
Quality management needed
Signal category
Operations

Topics and mentions

Regions named

  • United States

Extraction

Confidence
High
Relevance
90%
Sentiment
Negative
Detected
Feb 24, 2026
signal_type
sec-10k
signal_subtype
qualityIssue

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This page shows a preview. The full sec-10k record in the Signal API and MCP can also have these 8 fields. Some fields are empty for some signals.

Company

  • linkedin_urlValue in the API
  • industriesValue in the API
  • employee_count_lowValue in the API
  • employee_count_highValue in the API
  • revenueValue in the API
  • descriptionValue in the API

Signal

  • signal_nameValue in the API
  • associationValue in the API
Show the full JSONThe record on this page and the API request

GET /v1/signals/085e7d1d-78e6-49e9-b10d-8a7619184594 returns this record as JSON. POST /v1/companies/enrich returns every signal for abbott.com.

{
  "signal_id": "085e7d1d-78e6-49e9-b10d-8a7619184594",
  "signal_type": "sec-10k",
  "signal_subtype": "qualityIssue",
  "detected_at": "2026-02-24T09:18:11.335+00:00",
  "company": {
    "name": "Abbott",
    "domain": "abbott.com"
  },
  "data": {
    "detail": "A voluntary recall of infant formula from the Sturgis, Michigan facility led to an FDA consent decree. This significant regulatory action creates intense pressure to overhaul quality management systems (QMS), improve product traceability, and ensure stringent compliance to avoid future shutdowns, fines, and reputational damage.",
    "metrics": {
      "timeframe": "current_year"
    },
    "summary": "Entered into FDA consent decree following major infant formula recall",
    "excerpts": "in February 2022, Abbott initiated a voluntary recall of certain powder infant formula products manufactured at its facility in Sturgis, Michigan at which time it temporarily stopped manufacturing at the facility.",
    "relevance": 0.9,
    "sentiment": "negative",
    "confidence": "high",
    "source_url": "https://www.sec.gov/Archives/edgar/data/1800/000162828026010185/abt-20251231.htm",
    "filing_date": "2026-02-20",
    "filing_year": 2026,
    "fiscal_year_end": "12/31",
    "sales_relevance": "Quality management needed",
    "signal_category": "operations",
    "regions_mentioned": [
      "United States"
    ]
  }
}

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