FDA Drug recall · Reported August 12, 2026
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
Presence of Particulate Matter; identified as stainless steel
Sunny Pharmtech Inc. recalled Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufact… - a critical-severity action.
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufact… was recalled by Sunny Pharmtech Inc. in August 12, 2026. Reason: Presence of Particulate Matter; identified as stainless steel. Check the official notice for the remedy. Verify recall #D-0743-2026 with the FDA Drug before acting.
The recall
Sunny Pharmtech Inc. issued this critical-severity FDA Drug recall-Presence of Particulate Matter; identified as stainless steel.
- Critical
- severity level
- Class I
- classification
- August 12, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0743-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0743-2026) was formally reported on August 12, 2026, with the manufacturer initiating the action on July 17, 2026. It is classified under Critical severity (Class I), with a current status of Ongoing. Sunny Pharmtech Inc. is listed as the recalling firm, operating out of Taoyuan City. Federal records list the affected scope as 4,077 vials.
The documented reason for this recall is: Presence of Particulate Matter; identified as stainless steel Distribution data in the federal record shows the product reached: USA Nationwide. 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 - 14,472 drugs & medications recalls on record
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
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
Reason for recall
Presence of Particulate Matter; identified as stainless steel
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0743-2026 |
| Date reported | August 12, 2026 |
| Date initiated | July 17, 2026 |
| Recalling firm | Sunny Pharmtech Inc. |
| Firm location | Taoyuan City |
| Affected scope | 4,077 vials |
| Distribution | USA Nationwide |
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-0743-2026) 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.
- 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.
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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.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026