CLASS I Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
Epinephrine (L-Adrenaline), USP, CAS 51-43-4 amber recalled
Spectrum Laboratory Products is recalling Epinephrine (L-Adrenaline), USP, CAS 51-43-4 amber in a, distributed nationwide in the US. The recall was initiated on 19 Dec 2022 and the FDA has classified it as Class I.
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-0179-2023
- FDA event ID
- 91381
- Recalling firm
- Spectrum Laboratory Products, New Brunswick, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Dec 2022
- FDA classified
- 25 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Allergy Medication
Timeline
| 19 Dec 2022 | Recall initiated by company | |
| 25 Jan 2023 | Classified by FDA | +37 days |
| 1 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130
Where it was distributed
Nationwide in the USA, Puerto Rico and Canada
Questions about this recall
Why was it recalled?
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Which lots are affected?
Lot # 1KG0865 EXP 31-Mar-2023
Where was it sold?
Nationwide in the USA, Puerto Rico and Canada
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
1 other product · FDA event 91381| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Epinephrine (L-Adrenaline), USP, CAS recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
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 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 | Fentanyl Citrate USP, Active Pharmaceutical Ingredient recalled | Spectrum Laboratory Products | Foreign Material | 4 states |
| Drug | CLASS II | Levonorgestrel, U.S.P. active pharmaceutical ingredient recalled | Spectrum Laboratory Products | Manufacturing (CGMP) Deviations | Nationwide |
Other Epinephrine (l-adrenaline recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |