Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Recall #: D-0508-2024
Initiated: April 29, 2024

Compiled from official public sources by the publisher. · Updated September 2026

Hikma Injectables USA Inc recalled Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe… - a critical-severity action.

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe… was recalled by Hikma Injectables USA Inc in May 29, 2024. Reason: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.. Check the official notice for the remedy. Verify recall #D-0508-2024 with the FDA Drug before acting.

The recall

Hikma Injectables USA Inc issued this critical-severity FDA Drug recall-Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine..

Critical
severity level: Class I
classification: May 29, 2024
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0508-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. Distribution scope (see Distribution below) 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, 6 from FDA Drug - 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Reason for recall

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Completed
Recall number	D-0508-2024
Date reported	May 29, 2024
Date initiated	April 29, 2024
Recalling firm	Hikma Injectables USA Inc
Firm location	Dayton, NJ
Affected scope	Not disclosed
Distribution	CO, GA, PA, SD, WA

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-0508-2024) 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? ▼

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25. Recalled by Hikma Injectables USA Inc.

Why was this product recalled? ▼

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 29, 2024. Severity: Critical. Recall number: D-0508-2024.

Where was the recalled product distributed? ▼

Distribution: CO, GA, PA, SD, WA.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported May 29, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026