The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0180-2023·Announced 2023-02-01

Epinephrine API Recalled for Discoloration and Reduced Efficacy

Spectrum Laboratory Products recalls Epinephrine (L-Adrenaline) USP in multiple lot sizes due to discoloration that could reduce the product's effectiveness. The recall affects shipments 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: FDA Class I classification establishes a minimum severity score of 4 per rubric rules. The discoloration could reduce the pharmaceutical's potency, which directly affects patient safety for this critical medication.

Plain-English summary

Spectrum Laboratory Products, Inc. is recalling Epinephrine (L-Adrenaline), USP (CAS 51-43-4), a pharmaceutical active ingredient packaged in amber glass bottles within vacuum-sealed pouches. Affected sizes include 100 G, 1 G, 25 G, and 5 G, with specific lot numbers 2KL0353 (expiration 30-Sep-2023) and 2KF0151 (expiration 31-Mar-2023).

The recall was initiated due to discoloration of the epinephrine API, which could result in reduced product potency and effectiveness. This is a Class I recall, the FDA's most serious classification.

The affected lots were distributed nationwide in the United States, Puerto Rico, and Canada.

The recalled product

Product
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.
Manufacturer
Spectrum Laboratory Products, Inc.
Category
Drug
Hazard

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 (4)

  • Lot # (a) (b) (c) (d) lot 2KL0353
  • EXP 30-Sep-2023
  • 2KF0151
  • 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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