Chattem Inc FDA Record
- Latest inspection VAI · Aug 22, 2025
- Last warning letter 2011
Chattem Inc has 2 FDA recalls, 27 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Chattem Inc, the most recent on Jan 28, 2011.
- Latest recall
- D-0362-2025 · Class II · Mar 26, 2025
- Latest inspection
- Aug 22, 2025 · VAI
- Latest 510(k)
- Jul 25, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 2 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 27 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Chattem Inc: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 2 | 0 |
| 2024 | 2 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
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Chattem Inc FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jan 28, 2011 · Record page |
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… | Mar 26, 2025 |
| D-0266-2025 | Class II | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per… | Mar 4, 2025 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 22, 2025 | Chattanooga, TN | Drugs | Voluntary Action Indicated (VAI) | 1022556 |
| Oct 23, 2024 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| Feb 28, 2024 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| Jun 13, 2023 | Chattanooga, TN | Food/Cosmetics | No Action Indicated (NAI) | 1022556 |
| Oct 1, 2021 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| Mar 13, 2020 | Chattanooga, TN | Drugs | Voluntary Action Indicated (VAI) | 1022556 |
| Oct 9, 2018 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| May 4, 2017 | Chattanooga, TN | Drugs | No Action Indicated (NAI) | 1022556 |
| Mar 2, 2017 | Chattanooga, TN | Drugs | No Action Indicated (NAI) | 1022556 |
| Sep 2, 2016 | Chattanooga, TN | Devices | No Action Indicated (NAI) | 1022556 |
| Aug 3, 2016 | Morristown, NJ | Drugs | Voluntary Action Indicated (VAI) | 2222017 |
| May 27, 2016 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| Oct 30, 2015 | Morristown, NJ | Drugs | Voluntary Action Indicated (VAI) | 2222017 |
| Mar 27, 2015 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| Jul 17, 2014 | Morristown, NJ | Drugs | Voluntary Action Indicated (VAI) | 2222017 |
| Mar 14, 2014 | Chattanooga, TN | Drugs | No Action Indicated (NAI) | 1022556 |
| Jul 12, 2013 | Chattanooga, TN | Food/Cosmetics | No Action Indicated (NAI) | 1022556 |
| Apr 1, 2013 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| Oct 11, 2012 | Morristown, NJ | Drugs | No Action Indicated (NAI) | 2222017 |
| May 17, 2012 | Morristown, NJ | Drugs | Voluntary Action Indicated (VAI) | 2222017 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Chattem Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1022556 | Chattanooga, TN | 11 | Aug 22, 2025 |
| FEI 2222017 | Morristown, NJ | 16 | Oct 23, 2024 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K131159 | SMARTRELIEF | Jul 25, 2013 |
Chattem Inc and the FDA: common questions
Has Chattem Inc received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Chattem Inc. The most recent is dated Jan 28, 2011.
Has Chattem Inc received an FDA Form 483?
FDA has not published a Form 483 for "Chattem Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Chattem Inc?
The most recent FDA inspection on file ended Aug 22, 2025 at Chattanooga, TN and was classified VAI. FDA has 27 inspections of Chattem Inc on file, 1 of them classified OAI (official action indicated).
Has Chattem Inc had an FDA recall?
Yes. Chattem Inc has 2 FDA recalls on record. The most recent started Mar 26, 2025.
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