The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0179-2023·Announced 2023-02-01

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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category
Drug — Pharmaceutical Ingredient / Injectable
Hazard
Affected units
1

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Spectrum Laboratory Products, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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