Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- Brands
- Everolimus, Endo USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Everolimus, Endo USA
- Product type
- Oral Tablet
- Model numbers
- Lot #: 550172301, Exp. Date January 2026
- UPC codes
- 49884-119, 49884-125, 49884-127, 49884-128, 49884-119-52, 49884-119-91, 49884-125-52, 49884-125-91 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 5, 2025
Reported by FDA DRUG
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Endo USA, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Everolimus is an immunosuppressant medication used to prevent organ rejection in transplant patients. The 5mg tablet is prescription-only and distributed nationwide in the United States.
Why This Is Dangerous
The product contains an impurity (IP-C) out of specification. This could affect safety and efficacy for patients taking the recalled tablets.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Patients may need to switch medications under medical supervision. The recall could disrupt treatment plans and requires prompt action by providers and patients.
Practical Guidance
How to identify if yours is affected
- Check the label for NDC 49884-125-91
- Check Lot number 550172301 on the carton
- Verify Expiration date January 2026
- Confirm packaging: 28 tablets per carton (4 blister strips x 7)
Where to find product info
NDC, lot number, and expiration are on the carton and blister-pack labeling.
What timeline to expect
Recall processes for refunds/replacements typically follow internal company timelines and FDA guidance; exact duration not specified.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a consumer complaint with the FDA if the company is unresponsive.
- Consult your pharmacist or physician for guidance on alternative therapies.
How to prevent similar issues
- Verify NDC numbers when dispensing or acquiring medications.
- Be alert for recall notices from manufacturers and the FDA.
- Ask pharmacists to confirm product lot details before dispensing high-risk drugs.
Documentation advice
Keep the recall notice, the product packaging, and any correspondence with Endo USA. Document batch/lot, NDC, and expiration for records.
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Product Details
Cartons: 1,041. Product: Everolimus 5mg tablets. NDC: 49884-125-91. Lot: 550172301. Expiration: January 2026. Pack size: 28 tablets per carton (4 blister strips x 7 tablets). Rx only. Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977. Sold nationwide within the United States. Recall date: 2025-09-05. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,041 cartons recalled nationwide
- Everolimus 5mg tablets, NDC 49884-125-91
- Lot 550172301, Exp January 2026
- Manufactured by Par Pharmaceutical, Chestnut Ridge, NY 10977
- Rx only; distributed nationwide within the United States
- Hazard level: HIGH; Impurity IP-C out of specification
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Safety Guide
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