Recall archive / FDA company announcement

Spectrum: Epinephrine bulk API — FDA announcement Jan 9, 2023

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jan 9, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Epinephrine bulk API
Reason: Product discoloration
Classification: Not supplied
Recalling firm: Spectrum Laboratory Products Inc.
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: ce3922212e3b0594

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Epinephrine (L-Adrenaline) USP bulk API Powder, is used in manufacturing and compounding of finished dose epinephrine prescription products which can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest. The Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch. NDC’s, Package sizes, lot numbers and expiration dates can be found in the table below. The affected Epinephrine, USP product can be identified by Spectrum catalog number EP130. Product was distributed directly from Spectrum facilities nationwide in the USA and to Canada.; Product \| NDC \| Package Size \| Lot # \| Exp Date; Epinephrine, USP (Product code EP130); 49452-2740-2 \| 1 KG \| 1KG0865 \| 31-Mar-2023; 49452-2740-1 \| 100 GM \| 2KL0353 2KF0151 \| 30-Sep-2023 31-Mar-2023; 49452-2740-4 \| 1 GM; 49452-2740-3 \| 25 GM; 49452-2740-5 \| 5 GM

Label field

Details supplied by the agency

Lot, code or applicability

Epinephrine (L-Adrenaline) USP bulk API Powder, is used in manufacturing and compounding of finished dose epinephrine prescription products which can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest. The Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch. NDC’s, Package sizes, lot numbers and expiration dates can be found in the table below. The affected Epinephrine, USP product can be identified by Spectrum catalog number EP130. Product was distributed directly from Spectrum facilities nationwide in the USA and to Canada.; Product | NDC | Package Size | Lot # | Exp Date; Epinephrine, USP (Product code EP130); 49452-2740-2 | 1 KG | 1KG0865 | 31-Mar-2023; 49452-2740-1 | 100 GM | 2KL0353 2KF0151 | 30-Sep-2023 31-Mar-2023; 49452-2740-4 | 1 GM; 49452-2740-3 | 25 GM; 49452-2740-5 | 5 GM

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product	NDC	Package Size	Lot #	Exp Date
Epinephrine, USP (Product code EP130)
	49452-2740-2	1 KG	1KG0865	31-Mar-2023
	49452-2740-1	100 GM	2KL0353 2KF0151	30-Sep-2023 31-Mar-2023
	49452-2740-4	1 GM
	49452-2740-3	25 GM
	49452-2740-5	5 GM

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Jan 9, 2023
Company announcement date: Jan 9, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.