Mead Johnson & Company LLC
FDA Regulatory Profile
Mead Johnson & Company LLC has 2 FDA recalls (2 Class I), 67 inspections, 1 510(k) clearance and 3 compliance actions on record.
- Latest recall
- F-0809-2024 · Class I · Dec 30, 2023
- Latest inspection
- Jan 22, 2026 · VAI
- Latest 510(k)
- Mar 4, 1986
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 2 (2 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 67 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 3 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| F-0809-2024 | Class I | Enfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and 19.8 OZ). UPC… | Dec 30, 2023 |
| F-0623-2023 | Class I | ENFAMIL PROSOBEE PWD 12.9OZ (6CAN) US | Feb 19, 2023 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jan 22, 2026 | Zeeland, MI | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1812170 |
| Nov 14, 2025 | Wanamingo, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2122612 |
| Jul 2, 2025 | Evansville, IN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1819504 |
| Jan 10, 2025 | Zeeland, MI | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1812170 |
| Sep 18, 2024 | Evansville, IN | Food/Cosmetics | No Action Indicated (NAI) | 1819504 |
| Jan 10, 2024 | Zeeland, MI | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1812170 |
| Jan 10, 2024 | Wanamingo, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2122612 |
| Dec 1, 2023 | Zeeland, MI | Food/Cosmetics | No Action Indicated (NAI) | 1812170 |
| Sep 13, 2023 | Evansville, IN | Food/Cosmetics | No Action Indicated (NAI) | 1819504 |
| Jun 8, 2023 | Wanamingo, MN | Food/Cosmetics | No Action Indicated (NAI) | 2122612 |
| Feb 23, 2023 | Zeeland, MI | Food/Cosmetics | Official Action Indicated (OAI) | 1812170 |
| Jan 9, 2023 | Wanamingo, MN | Food/Cosmetics | Official Action Indicated (OAI) | 2122612 |
| Dec 14, 2022 | Zeeland, MI | Food/Cosmetics | No Action Indicated (NAI) | 1812170 |
| Oct 27, 2022 | Evansville, IN | Food/Cosmetics | No Action Indicated (NAI) | 1819504 |
| Jul 6, 2022 | Zeeland, MI | Food/Cosmetics | Official Action Indicated (OAI) | 1812170 |
| Apr 7, 2022 | Wanamingo, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2122612 |
| Aug 26, 2021 | Evansville, IN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1819504 |
| Jul 23, 2021 | Wanamingo, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2122612 |
| May 31, 2019 | Wanamingo, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2122612 |
| Mar 21, 2019 | Zeeland, MI | Food/Cosmetics | No Action Indicated (NAI) | 1812170 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K860247 | INSTA KIT FOR GROUP A STREP ID | Mar 4, 1986 |