Epinephrine Active Pharmaceutical Ingredient Recalled for Discoloration
Spectrum Laboratory Products is recalling Epinephrine API lot 1KG0865 due to discoloration that may compromise product effectiveness. The product was distributed nationwide in the USA, Puerto Rico, and Canada.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as FDA Class I, the highest classification for drug recalls. While no illnesses or deaths have been reported, the potential for reduced effectiveness of an emergency medication such as epinephrine constitutes a severe public health concern.
Plain-English summary
Spectrum Laboratory Products, Inc. is recalling Epinephrine (L-Adrenaline), USP, in 1 KG amber glass bottles due to discoloration that could result in a less effective product. The affected lot is 1KG0865 with an expiration date of March 31, 2023.
The product was distributed nationwide in the United States, Puerto Rico, and Canada for pharmaceutical use. This is a Class I recall, the FDA's highest classification.
If you have this product, do not use it and contact your healthcare provider or pharmacy for a replacement. Report any adverse events related to this product to the FDA.
The recalled product
- Product
- 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
- Manufacturer
- Spectrum Laboratory Products, Inc.
- Hazard
- discoloration
- reduced-efficacy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 1KG0865 EXP 31-Mar-2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27