Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported May 22, 2024
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Presence of Particulate Matter: Potential for black particulates in the drug product.
Sagent Pharmaceuticals recalled MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1… - a moderate-severity action.
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1… was recalled by Sagent Pharmaceuticals in May 22, 2024. Reason: Presence of Particulate Matter: Potential for black particulates in the drug product.. Check the official notice for the remedy. Verify recall #D-0499-2024 with the FDA Drug before acting.
The recall
Sagent Pharmaceuticals issued this moderate-severity FDA Drug recall-Presence of Particulate Matter: Potential for black particulates in the drug product..
- Moderate
- severity level
- Class II
- classification
- May 22, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0499-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0499-2024) was formally reported on May 22, 2024, with the manufacturer initiating the action on April 25, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Sagent Pharmaceuticals is listed as the recalling firm, operating out of Schaumburg, IL. Federal records list the affected scope as 14,360 vials.
The documented reason for this recall is: Presence of Particulate Matter: Potential for black particulates in the drug product. Distribution data in the federal record shows the product reached: Nationwide 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, 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 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
14,360 vials
Related Recalls
6
5 from same agency
Product description
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Reason for recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0499-2024 |
| Date reported | May 22, 2024 |
| Date initiated | April 25, 2024 |
| Recalling firm | Sagent Pharmaceuticals |
| Firm location | Schaumburg, IL |
| Affected scope | 14,360 vials |
| Distribution | Nationwide 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-0499-2024) 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? ▼
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10. Recalled by Sagent Pharmaceuticals. Units affected: 14,360 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Potential for black particulates in the drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 22, 2024. Severity: Moderate. Recall number: D-0499-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0499-2024) 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 22, 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.