Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported February 1, 2023
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
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Spectrum Laboratory Products, Inc. recalled Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed … - a critical-severity action.
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed … was recalled by Spectrum Laboratory Products, Inc. in February 1, 2023. Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in le…. Check the official notice for the remedy. Verify recall #D-0179-2023 with the FDA Drug before acting.
The recall
Spectrum Laboratory Products, Inc. issued this critical-severity FDA Drug recall-Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in le….
- Critical
- severity level
- Class I
- classification
- February 1, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0179-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0179-2023) was formally reported on February 1, 2023, with the manufacturer initiating the action on December 19, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Spectrum Laboratory Products, Inc. is listed as the recalling firm, operating out of New Brunswick, NJ. Federal records list the affected scope as 1 bottle.
The documented reason for this recall is: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product Distribution data in the federal record shows the product reached: Nationwide in the USA, Puerto Rico and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1 bottle
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0179-2023 |
| Date reported | February 1, 2023 |
| Date initiated | December 19, 2022 |
| Recalling firm | Spectrum Laboratory Products, Inc. |
| Firm location | New Brunswick, NJ |
| Affected scope | 1 bottle |
| Distribution | Nationwide in the USA, Puerto Rico and Canada |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0179-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Spectrum Laboratory Products, Inc.. Units affected: 1 bottle.
Why was this product recalled? ▼
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2023. Severity: Critical. Recall number: D-0179-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA, Puerto Rico and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0179-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 1, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.