Chattem Inc
FDA Regulatory Profile
Chattem Inc appears in FDA public data with 2 recalls, 1 510(k) clearance, 27 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0362-2025, Class II) was initiated on March 26, 2025. Its most recent 510(k) clearance was granted on July 25, 2013.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 27
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0362-2025 | Class II | Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Ch | March 26, 2025 |
| D-0266-2025 | Class II | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per | March 4, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131159 | SMARTRELIEF | July 25, 2013 |