Quick Facts at a Glance
- Recall Date
- September 19, 2025
- Hazard Level
- HIGH
- Brands
- Atorvastatin Calcium, Ascend Laboratories, LLC
- 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
- Atorvastatin Calcium, Ascend Laboratories, LLC
- Product type
- Prescription statin tablet
- Model numbers
- 25140933, 25140477, 24144254, 24144163, 24143995
- UPC codes
- 67877-511, 67877-512, 67877-513, 67877-514, 67877-511-90, 67877-511-05, 67877-511-10, 67877-511-55 +6 more
- Sizes
- 90-count, 500-count, 1000-count
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 19, 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 Dissolution Specifications
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Atorvastatin calcium tablets are a prescription cholesterol-lowering medication used to reduce risk of cardiovascular events. The 40 mg strength is commonly prescribed for adults with high cholesterol or mixed dyslipidemia.
Why This Is Dangerous
Dissolution specification failures mean the tablet may not dissolve as intended in the body, potentially reducing the drug's therapeutic effect.
Industry Context
Not specified in the provided data.
Real-World Impact
The recall could disrupt treatment for patients relying on these tablets. Patients should seek guidance from healthcare providers and pharmacy staff to ensure continued lipid management.
Practical Guidance
How to identify if yours is affected
- 1. Locate the bottle label
- 4. Compare expiry dates shown on the bottle
- 5. Contact Ascend Laboratories for refunds or replacements
Where to find product info
Recall notice on FDA enforcement page and product labeling for NDC and lot numbers.
What timeline to expect
Refunds or replacements typically processed within 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with Ascend Laboratories
- File a complaint with FDA/MedWatch if no resolution is reached
- Consult your pharmacist for alternatives and dosing adjustments
How to prevent similar issues
- Always verify NDC and lot numbers before dispensing or taking a medication
- Ask your pharmacist to confirm recall status when receiving a medication with a recall,
- Keep a list of current medications and associated lot codes to make recalls easier.
Documentation advice
Keep the recall notice, bottle label, receipts, prescription information, and communications with the manufacturer for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
NDC 67877-513-90 – 90-count; NDC 67877-513-05 – 500-count; NDC 67877-513-10 – 1000-count. Manufactured by Alkem Laboratories, Ltd., India. Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. Sold nationwide in the United States. Lot numbers: 25140933; 25140477; 24144254; 24144163; 24143995. Expirations: 25140477 – Feb 2027; 24144254 – Dec 2026; 24144163 – Oct 2026; 24143995 – Sep 2026. Recall date: 2025-09-19. Status: Active. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Expirations: Feb 2027; Dec 2026; Oct 2026; Sep 2026
- Manufactured by: Alkem Laboratories, Ltd., India
- Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
- Recall date: 2025-09-19; Status: Active
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.