Quick Facts at a Glance
- Recall Date
- September 19, 2025
- Hazard Level
- HIGH
- Brands
- Ascend Laboratories, Alkem Laboratories
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
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
- Ascend Laboratories, Alkem Laboratories
- Product type
- Prescription statin tablet
- Model numbers
- NDC 67877-512-90, NDC 67877-512-05, NDC 67877-512-10
- 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
Atorvastatin calcium tablets are prescribed to lower cholesterol and reduce cardiovascular risk. The recalled lots were distributed nationwide in the United States.
Why This Is Dangerous
Dissolution failure can lead to inconsistent absorption, potentially reducing efficacy and impacting lipid control.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients may experience subtherapeutic dosing which could affect cholesterol management and cardiovascular risk.
Practical Guidance
How to identify if yours is affected
- Verify packaging lot and expiration to ensure recall applicability
- Cross-check with medical provider's prescription information
Where to find product info
NDC codes on the bottle label and packaging; recall notification letters to healthcare facilities
What timeline to expect
Recall notifications may lead to refunds or replacements; processing times vary
If the manufacturer is unresponsive
- Document all communications with Ascend Laboratories
- File a consumer complaint with the FDA if there is no timely response
- Consult a healthcare provider for alternatives during the recall period
How to prevent similar issues
- Always verify NDC numbers before dispensing or consuming generic medications
- Purchase from reputable pharmacies or verified distributors
- Keep recall communications and packaging for reference
Documentation advice
Retain recall notices, packaging, prescription records, and correspondence with the manufacturer
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Product Details
Product: Atorvastatin Calcium Tablets USP, 20 mg, Rx Only. 90-count NDC 67877-512-90; 500-count NDC 67877-512-05; 1000-count NDC 67877-512-10. Manufactured by: Alkem Laboratories, Ltd. India. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Sold nationwide in the U.S.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed nationwide in the U.S.
- Hazard: Dissolution specification failures
- Active recall as of 2025-10-22
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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