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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Spectrum Epinephrine API Recalled for Discoloration

Agency Publication Date: January 25, 2023
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Summary

Spectrum Laboratory Products, Inc. is recalling 8 units of Epinephrine (L-Adrenaline) USP active pharmaceutical ingredient (API) due to reports of discoloration. Discolored epinephrine may be less effective than required, which is a critical safety issue for a medication used in emergency life-saving situations. The recall affects bottles in sizes of 1 g, 5 g, 25 g, 100 g, and 1 kg distributed nationwide in the USA, Puerto Rico, and Canada. No injuries or incidents have been reported to date.

Risk

Discoloration indicates the epinephrine has degraded, which can significantly reduce its potency and effectiveness. Using a less effective product during an emergency medical situation, such as a severe allergic reaction, could lead to serious health consequences or treatment failure.

What You Should Do

  1. This recall involves Spectrum brand Epinephrine (L-Adrenaline), USP (CAS 51-43-4) active pharmaceutical ingredient packaged in amber glass bottles with Product Code EP130.
  2. Identify affected products by checking for lot numbers 1KG0865 (Exp 31-Mar-2023), 2KL0353 (Exp 30-Sep-2023), or 2KF0151 (Exp 31-Mar-2023) printed on the bottle label.
  3. Stop using the recalled product immediately and quarantine any remaining stock to prevent further use.
  4. Contact Spectrum Chemical Mfg. Corp. at (800) 424-9300 or visit www.SpectrumChemical.com to arrange for the return of the affected material.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Epinephrine (L-Adrenaline), USP (1 KG)by Spectrum
Variants: 1 KG, Amber glass bottle
Model:
EP130
Lot Numbers:
1KG0865 (Exp 31-Mar-2023)

CAS 51-43-4; Repackaged by Spectrum Chemical Mfg. Corp.; Rx only.

Product: Epinephrine (L-Adrenaline), USP (Multiple Sizes)by Spectrum
Variants: 100 G, 1 G, 25 G, 5 G, Amber glass bottle
Model:
EP130
Lot Numbers:
2KL0353 (Exp 30-Sep-2023)
2KF0151 (Exp 31-Mar-2023)

CAS 51-43-4; Repackaged by Spectrum Chemical Mfg. Corp.; Rx only.

Product Images

Label, spectrum Epinephrine 1 g, Lot 2KF0151

Label, spectrum Epinephrine 1 g, Lot 2KF0151

Label, spectrum Epinephrine 1 g, Lot 2KL0353

Label, spectrum Epinephrine 1 g, Lot 2KL0353

Label, spectrum Epinephrine 1 kg, Lot 1KG0865

Label, spectrum Epinephrine 1 kg, Lot 1KG0865

Label, spectrum Epinephrine 5 g , Lot 2KF0151

Label, spectrum Epinephrine 5 g , Lot 2KF0151

Label, spectrum Epinephrine 5 g, Lot 2KL0353

Label, spectrum Epinephrine 5 g, Lot 2KL0353

Label, spectrum Epinephrine 25 g, Lot 2KF0151

Label, spectrum Epinephrine 25 g, Lot 2KF0151

Label, spectrum Epinephrine 25 g, Lot 2KL0353

Label, spectrum Epinephrine 25 g, Lot 2KL0353

Label, spectrum Epinephrine 100 g, Lot 2KF0151

Label, spectrum Epinephrine 100 g, Lot 2KF0151

Label, spectrum Epinephrine 100 g, Lot 2KL0353

Label, spectrum Epinephrine 100 g, Lot 2KL0353

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91381
Status: Resolved
Manufacturer: Spectrum Laboratory Products, Inc.
Sold By: Nationwide distributors
Manufactured In: United States
Units Affected: 2 products (1 bottle; 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.