CLASS II Drug recall · Reported 23 Oct 2019 · FDA Enforcement Report
Fentanyl Citrate USP, Active Pharmaceutical Ingredient recalled
Spectrum Laboratory Products is recalling Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP, distributed in California, Colorado, Maryland, South Carolina. The recall was initiated on 12 Sep 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0141-2020
- FDA event ID
- 83796
- Recalling firm
- Spectrum Laboratory Products, Gardena, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2019
- FDA classified
- 15 Oct 2019
- Reported
- 23 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 12 Sep 2019 | Recall initiated by company | |
| 15 Oct 2019 | Classified by FDA | +33 days |
| 23 Oct 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Where it was distributed
Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
Questions about this recall
Why was it recalled?
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Which lots are affected?
Lot # 1HE0899, 1IB0005, Exp 02/28/2023
Where was it sold?
Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spectrum Laboratory Products
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS 51-43-4 amber recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Ranitidine Hydrochloride (powder) recalled | Spectrum Laboratory Products | Nitrosamine Impurity | 11 states |
| Drug | CLASS II | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol recalled | Spectrum Laboratory Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Levonorgestrel, U.S.P. active pharmaceutical ingredient recalled | Spectrum Laboratory Products | Manufacturing (CGMP) Deviations | Nationwide |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |