Quick Facts at a Glance
- Recall Date
- September 19, 2025
- Hazard Level
- HIGH
- Brands
- ATORVASTATIN CALCIUM, Ascend Laboratories
- 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
- Product type
- Atorvastatin Calcium Tablets USP, 10 mg
- Model numbers
- 90-count bottle (NDC 67877-511-90), 500-count bottle (NDC 67877-511-05), 1000-count bottle (NDC 67877-511-10), Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458 +4 more
- UPC codes
- 67877-511, 67877-512, 67877-513, 67877-514, 67877-511-90, 67877-511-05, 67877-511-10, 67877-511-55 +6 more
- 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
This medication is a generic statin used to lower cholesterol. It is distributed nationwide for adults with elevated cholesterol or cardiovascular risk.
Why This Is Dangerous
A failed dissolution specification means the tablet could fail to release the active drug as intended, leading to reduced or inconsistent drug exposure.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Patients may experience reduced therapeutic effect or require dosage adjustments. The recall is high risk but no injuries have been reported.
Practical Guidance
How to identify if yours is affected
- Verify bottle size: 90-count, 500-count, or 1000-count.
- Note Lot numbers listed in the recall information and compare to your bottle.
Where to find product info
NDC is printed on the bottle label. Lot numbers appear on the bottle or packaging. Expiration dates are listed on the label.
What timeline to expect
Refunds or replacements timelines are not specified in the recall; follow-up from Ascend Laboratories or the FDA may provide guidance.
If the manufacturer is unresponsive
- File a report with FDA MedWatch at 1-800-FDA-1088 if the company is unresponsive.
- Consult your pharmacist or physician for interim guidance.
How to prevent similar issues
- Verify NDC before purchasing similar statin medications.
- Buy from reputable pharmacies and confirm packaging integrity.
- Discuss any recalls with your healthcare provider at your next visit.
Documentation advice
Keep the recall notice, bottle labels, NDCs, lot numbers, and any correspondence with Ascend Laboratories. Photograph the bottle and label for records.
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Product Details
Product: ATORVASTATIN CALCIUM Tablets USP, 10 mg; NDCs: 67877-511-90 (90-count), 67877-511-05 (500-count), 67877-511-10 (1000-count); Lot numbers include 25141249 and 2414-series with Exp dates: Feb 2027, Nov 2026, Sep 2026, Jul 2026, among others; Distributed nationwide in the United States; Manufactured by Alkem Laboratories, Ltd. India; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054; Recall date: 2025-09-19; Status: ACTIVE; Quantity: 141,984 bottles.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 141,984 bottles recalled nationwide
- Bottle sizes: 90-count, 500-count, 1000-count
- Manufactured by Alkem Laboratories, Ltd. India
- Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054
- Hazard: Failed dissolution specifications
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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