Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported July 29, 2026
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
Presence of Particulate Matter: Hair was found in products
Fresenius Kabi USA, LLC recalled Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL),… - a moderate-severity action.
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL),… was recalled by Fresenius Kabi USA, LLC in July 29, 2026. Reason: Presence of Particulate Matter: Hair was found in products. Check the official notice for the remedy. Verify recall #D-0727-2026 with the FDA Drug before acting.
The recall
Fresenius Kabi USA, LLC issued this moderate-severity FDA Drug recall-Presence of Particulate Matter: Hair was found in products.
- Moderate
- severity level
- Class II
- classification
- July 29, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0727-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0727-2026) was formally reported on July 29, 2026, with the manufacturer initiating the action on July 16, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Fresenius Kabi USA, LLC is listed as the recalling firm, operating out of Lake Zurich, IL. Federal records list the affected scope as 92,600 vials.
The documented reason for this recall is: Presence of Particulate Matter: Hair was found in products Distribution data in the federal record shows the product reached: Nationwide within in the USA. 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, 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,436 drugs & medications recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
92,600 vials
Related Recalls
6
6 from same agency
Product description
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
Reason for recall
Presence of Particulate Matter: Hair was found in products
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0727-2026 |
| Date reported | July 29, 2026 |
| Date initiated | July 16, 2026 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Firm location | Lake Zurich, IL |
| Affected scope | 92,600 vials |
| Distribution | Nationwide within in the USA |
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-0727-2026) 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? ▼
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05. Recalled by Fresenius Kabi USA, LLC. Units affected: 92,600 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Hair was found in products
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 29, 2026. Severity: Moderate. Recall number: D-0727-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide within in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0727-2026) 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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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 July 29, 2026. 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 August 2026.