Severity
Low
LowClass IIICompleted
FDA Drug recall · Reported May 8, 2024
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Labeling: Wrong Barcode
Hikma Injectables USA Inc recalled Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL ba… - a low-severity action.
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL ba… was recalled by Hikma Injectables USA Inc in May 8, 2024. Reason: Labeling: Wrong Barcode. Check the official notice for the remedy. Verify recall #D-0480-2024 with the FDA Drug before acting.
The recall
Hikma Injectables USA Inc issued this low-severity FDA Drug recall-Labeling: Wrong Barcode.
- Low
- severity level
- Class III
- classification
- May 8, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0480-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0480-2024) was formally reported on May 8, 2024, with the manufacturer initiating the action on April 30, 2024. It is classified under Low severity (Class III), with a current status of Completed. Hikma Injectables USA Inc is listed as the recalling firm, operating out of Dayton, NJ. Federal records list the affected scope as 1,895 bags.
The documented reason for this recall is: Labeling: Wrong Barcode Distribution data in the federal record shows the product reached: Nationwide within the United States. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,895 bags
Related Recalls
6
5 from same agency
Product description
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Reason for recall
Labeling: Wrong Barcode
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Completed |
| Recall number | D-0480-2024 |
| Date reported | May 8, 2024 |
| Date initiated | April 30, 2024 |
| Recalling firm | Hikma Injectables USA Inc |
| Firm location | Dayton, NJ |
| Affected scope | 1,895 bags |
| Distribution | Nationwide within the United States |
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-0480-2024) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05. Recalled by Hikma Injectables USA Inc. Units affected: 1,895 bags.
Why was this product recalled? ▼
Labeling: Wrong Barcode
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 8, 2024. Severity: Low. Recall number: D-0480-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0480-2024) 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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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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FDA Drug Moderate
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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 8, 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.