Time-Cap Laboratories, Inc. FDA Record
Time-Cap Laboratories, Inc. has 12 FDA recalls, 13 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Time-Cap Laboratories, Inc., the most recent on Apr 10, 2009.
- Latest recall
- D-0694-2018 · Class II · Jan 11, 2018
- Latest inspection
- Apr 24, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 12 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 13 | 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 11 | 0 |
| 2017 | 0 | 0 | 0 | 1 | 0 |
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Time-Cap Laboratories, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Apr 10, 2009 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0694-2018 | Class II | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01)… | Jan 11, 2018 |
| D-0691-2018 | Class II | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC… | Jan 11, 2018 |
| D-0690-2018 | Class II | Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC… | Jan 11, 2018 |
| D-0688-2018 | Class II | Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal… | Jan 11, 2018 |
| D-0687-2018 | Class II | Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50)… | Jan 11, 2018 |
| D-0695-2018 | Class II | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12)… | Jan 11, 2018 |
| D-0686-2018 | Class II | Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12)… | Jan 11, 2018 |
| D-0693-2018 | Class II | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18)… | Jan 11, 2018 |
| D-0692-2018 | Class II | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50)… | Jan 11, 2018 |
| D-0689-2018 | Class II | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC… | Jan 11, 2018 |
| D-0685-2018 | Class II | Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC… | Jan 11, 2018 |
| D-1055-2017 | Class II | Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time… | Jun 16, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 24, 2025 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Oct 10, 2023 | Farmingdale, NY | Food/Cosmetics | No Action Indicated (NAI) | 2431898 |
| Dec 18, 2019 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Mar 12, 2018 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Mar 10, 2016 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Jan 16, 2015 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Oct 25, 2013 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Mar 18, 2013 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Nov 18, 2011 | Farmingdale, NY | Veterinary | Voluntary Action Indicated (VAI) | 2431898 |
| Feb 17, 2011 | Farmingdale, NY | Veterinary | No Action Indicated (NAI) | 2431898 |
| Apr 1, 2010 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Jun 29, 2009 | Farmingdale, NY | Drugs | Voluntary Action Indicated (VAI) | 2431898 |
| Dec 5, 2008 | Farmingdale, NY | Drugs | Official Action Indicated (OAI) | 2431898 |
- 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 Time-Cap Laboratories, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2431898 | Farmingdale, NY | 13 | Apr 24, 2025 |
Time-Cap Laboratories, Inc. and the FDA: common questions
Has Time-Cap Laboratories, Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Time-Cap Laboratories, Inc.. The most recent is dated Apr 10, 2009.
Has Time-Cap Laboratories, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Time-Cap Laboratories, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Time-Cap Laboratories, Inc.?
The most recent FDA inspection on file ended Apr 24, 2025 at Farmingdale, NY and was classified VAI. FDA has 13 inspections of Time-Cap Laboratories, Inc. on file, 1 of them classified OAI (official action indicated).
Has Time-Cap Laboratories, Inc. had an FDA recall?
Yes. Time-Cap Laboratories, Inc. has 12 FDA recalls on record. The most recent started Jan 11, 2018.
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