Ascend Laboratories Recall Atorvastatin Calcium 40 mg Tablets for Failed Dissolution Specifications
Ascend Laboratories recalled Atorvastatin Calcium Tablets USP 40 mg, 90-count (NDC 67877-513-90), 500-count (NDC 67877-513-05), and 1,000-count (NDC 67877-513-10) nationwide in the United States. The batches failed dissolution specifications. Patients should stop using the medication and contact Ascend Laboratories, LLC or their healthcare provider for guidance.
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
- 2. Verify NDC 67877-513-90, 67877-513-05, or 67877-513-10
- 3. Check lot numbers: 25140933, 25140477, 24144254, 24144163, 24143995
- 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.
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.