---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-038773"
form_type: "8-K"
ticker: "ICCC"
cik: "0000811641"
company_name: "IMMUCELL CORP /DE/"
filed_at: "2025-12-29T23:59:59+00:00"
generated_at: "2026-05-16T12:11:47.696822+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# ImmuCell pauses Re-Tain after FDA incomplete letter, shifts focus to First Defense; $2.3M impairment

## Summary
- FDA issued Incomplete Letter for Re-Tain NADA on Dec 23 due to contract manufacturer inspection issues; four of five Technical Sections had Complete Letters.
- ImmuCell pauses further investment in Re-Tain; will complete studies and seek to license or partner the product.
- Non-cash impairment write-down of ~$2.3M on Re-Tain property, plant and equipment in Q4 2025.
- First Defense sales force increased by 50%, new U.S. territories created, international senior dairy executive to be hired.
- First Defense revenue grew from ~$4.4M to ~$27.8M (TTM Sep 30, 2025) with >13% CAGR over 15 years; targeting $900M global TAM.

## SEC filing metadata
- accession: 0001437749-25-038773
- form_type: 8-K
- ticker: ICCC
- cik: 0000811641
- company_name: IMMUCELL CORP /DE/
- filed_at: 2025-12-29T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.06, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/811641/000143774925038773/0001437749-25-038773-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/811641/000143774925038773/iccc20251224_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-038773
- JSON: https://secwatch.observer/filing/0001437749-25-038773.json
- Plain text: https://secwatch.observer/filing/0001437749-25-038773.txt

## Source-grounded claims
- claim_id: 0f0dfbfb4696032502c4343ea2fcf39ebd475719
  claim: IMMUCELL CORP /DE/ announced a impairment with charges of approximately $2.3 million affecting production of Re-Tain ®.
  evidence_excerpt: ImmuCell Corporation (“ImmuCell”) has announced strategy changes (see Item 8.01 below) that will result in a material charge for a non-cash impairment write-down of certain property, plant and equipment (primarily equipment) during the fourth quarter of 2025. The affected assets are ones relating to the production of Re-Tain ®. Some but not all of those assets will now be repurposed to manufacture First Defense ®. ImmuCell presently estimates the non-cash impact to profit to be approximately $2.3 million (subject to adjustment pursuant to review of alternate purposing and net realizable value to be completed as part of the financial closing for the quarter and year ending December 31, 2025).
  evidence_url: https://www.sec.gov/Archives/edgar/data/811641/000143774925038773/0001437749-25-038773-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.