Spectrum Laboratory Products, Inc.
FDA Regulatory Profile
Spectrum Laboratory Products, Inc. has 9 FDA recalls (2 Class I), 18 inspections, 0 510(k) clearances and 2 compliance actions on record.
- Latest recall
- D-0180-2023 · Class I · Dec 19, 2022
- Latest inspection
- Mar 20, 2026 · 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 | 9 (2 Class I) | 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 | 18 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0180-2023 | Class I | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed… | Dec 19, 2022 |
| D-0179-2023 | Class I | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx… | Dec 19, 2022 |
| D-0825-2020 | Class II | Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams… | Jan 14, 2020 |
| D-0628-2020 | Class II | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1… | Dec 11, 2019 |
| D-0141-2020 | Class II | Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA… | Sep 12, 2019 |
| D-0881-2017 | Class II | Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized… | Apr 13, 2017 |
| D-0882-2017 | Class II | Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only… | Apr 13, 2017 |
| D-1456-2016 | Class II | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New… | Aug 1, 2016 |
| D-0255-2015 | Class II | Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248… | Jul 18, 2014 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Mar 20, 2026 | Gardena, CA | Drugs | Voluntary Action Indicated (VAI) | 2020632 |
| Feb 19, 2025 | New Brunswick, NJ | Drugs | Voluntary Action Indicated (VAI) | 2246824 |
| Jan 31, 2024 | Gardena, CA | Veterinary | No Action Indicated (NAI) | 2020632 |
| Mar 24, 2023 | New Brunswick, NJ | Drugs | Official Action Indicated (OAI) | 2246824 |
| Jul 14, 2021 | New Brunswick, NJ | Drugs | Official Action Indicated (OAI) | 2246824 |
| Mar 12, 2021 | Gardena, CA | Drugs | Voluntary Action Indicated (VAI) | 2020632 |
| Mar 12, 2019 | New Brunswick, NJ | Food/Cosmetics | No Action Indicated (NAI) | 2246824 |
| Nov 16, 2018 | Gardena, CA | Drugs | Official Action Indicated (OAI) | 2020632 |
| Aug 25, 2016 | Gardena, CA | Drugs | No Action Indicated (NAI) | 2020632 |
| Mar 14, 2016 | New Brunswick, NJ | Veterinary | Voluntary Action Indicated (VAI) | 2246824 |
| Aug 16, 2013 | New Brunswick, NJ | Drugs | Voluntary Action Indicated (VAI) | 2246824 |
| Apr 23, 2013 | Gardena, CA | Drugs | No Action Indicated (NAI) | 2020632 |
| Dec 2, 2011 | New Brunswick, NJ | Veterinary | Voluntary Action Indicated (VAI) | 2246824 |
| Jun 29, 2011 | New Brunswick, NJ | Veterinary | No Action Indicated (NAI) | 2246824 |
| Aug 27, 2010 | Gardena, CA | Drugs | No Action Indicated (NAI) | 2020632 |
| Aug 11, 2010 | New Brunswick, NJ | Veterinary | No Action Indicated (NAI) | 2246824 |
| Jun 24, 2010 | Gardena, CA | Drugs | No Action Indicated (NAI) | 2020632 |
| Aug 14, 2009 | Gardena, CA | Drugs | No Action Indicated (NAI) | 2020632 |
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 2020632 | Gardena, CA | 9 | Mar 20, 2026 |
| FEI 2246824 | New Brunswick, NJ | 9 | Feb 19, 2025 |