Severity
Critical
CriticalClass ICompleted
FDA Drug recall · Reported May 29, 2024
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.
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
This FDA Drug action (record #D-0508-2024) was formally reported on May 29, 2024, with the manufacturer initiating the action on April 29, 2024. It is classified under Critical severity (Class I), with a current status of Completed. Hikma Injectables USA Inc is listed as the recalling firm, operating out of Dayton, NJ. 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.
The documented reason for this recall is: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. Distribution data in the federal record shows the product reached: CO, GA, PA, SD, WA. 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, 5 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications 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
Unknown
Related Recalls
6
5 from same agency
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
| 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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0508-2024) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 May 29, 2024. 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.