Prestige Brands Holdings
FDA Regulatory Profile
Prestige Brands Holdings has 4 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0766-2026 · Class II · Jul 29, 2026
- Latest inspection
- Jun 25, 2025 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 4 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0766-2026 | Class II | CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech… | Jul 29, 2026 |
| H-0260-2025 | Class II | Little Remedies¿ Honey Cough 4 FL OZ (118 mL) | Jun 18, 2025 |
| D-1352-2014 | Class III | PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5… | Apr 25, 2014 |
| D-1353-2014 | Class III | PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and… | Apr 25, 2014 |
Recent FDA Inspections
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.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3010282778 | Tarrytown, NY | 1 | Jun 25, 2025 |