LNK International, Inc.
FDA Regulatory Profile
LNK International, Inc. has 6 FDA recalls, 16 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0115-2025 · Class II · Nov 14, 2024
- Latest inspection
- Oct 28, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 6 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 16 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0115-2025 | Class II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen… | Nov 14, 2024 |
| D-0014-2023 | Class III | NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER… | Oct 11, 2022 |
| D-1472-2022 | Class III | Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton… | Aug 4, 2022 |
| D-0665-2021 | Class III | Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500… | Jul 7, 2021 |
| D-1630-2019 | Class II | Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz… | Jul 10, 2019 |
| D-0319-2015 | Class II | Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine… | Jul 18, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Oct 28, 2025 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jul 1, 2021 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Feb 8, 2019 | Hauppauge, NY | Drugs | Official Action Indicated (OAI) | 2432212 |
| Mar 7, 2017 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jan 25, 2016 | Hauppauge, NY | Drugs | No Action Indicated (NAI) | 2432212 |
| Jan 30, 2015 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jan 17, 2014 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jun 14, 2013 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| May 24, 2013 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| May 22, 2012 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jan 27, 2012 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Sep 14, 2011 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jan 26, 2011 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jan 14, 2010 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Jan 14, 2010 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 2432212 |
| Oct 2, 2008 | Hauppauge, NY | Drugs | No Action Indicated (NAI) | 2432212 |
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 2432212 | Hauppauge, NY | 16 | Oct 28, 2025 |