HIGH

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.

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

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

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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. 1. Locate the bottle label
  2. 2. Verify NDC 67877-513-90, 67877-513-05, or 67877-513-10
  3. 3. Check lot numbers: 25140933, 25140477, 24144254, 24144163, 24143995
  4. 4. Compare expiry dates shown on the bottle
  5. 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.

Key Facts

  • NDCs recalled: 67877-513-90; 67877-513-05; 67877-513-10
  • Lot numbers: 25140933; 25140477; 24144254; 24144163; 24143995
  • 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

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
25140933
25140477
24144254
24144163
24143995
UPC Codes
67877-511
67877-512
67877-513
+11 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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