Quick Facts at a Glance
- Recall Date
- September 19, 2025
- Hazard Level
- HIGH
- Brand
- 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
- Ascend Laboratories
- Product type
- Atorvastatin Calcium Tablets 80 mg
- Model numbers
- Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898 +3 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
Atorvastatin Calcium is a prescription statin used to lower cholesterol. Patients obtain this medication through pharmacies under physician guidance.
Why This Is Dangerous
If the tablet does not dissolve properly, the amount of active drug released can be inconsistent, potentially reducing efficacy or causing unexpected dosing.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients may experience reduced cholesterol management effectiveness or require a change in medication. No injuries have been reported in connection with this recall so far.
Practical Guidance
How to identify if yours is affected
- Verify NDC: 67877-514-90 or 67877-514-05.
- Check Lot numbers listed on the package (e.g., Lot#: 25140249).
- Check expiration date on the package (dates through 2026).
- Keep packaging until instructed by Ascend.
Where to find product info
Recall details available via the FDA enforcement report and Ascend Laboratories communications. Look for the lot numbers and expiration dates on the vial or bottle label.
What timeline to expect
The recall notice does not specify a refund or replacement timeline. Expect follow-up communications from Ascend Laboratories.
If the manufacturer is unresponsive
- Document all communications with Ascend Laboratories.
- File a complaint with the FDA if the company is unresponsive.
- Keep receipts and packaging for documentation.
How to prevent similar issues
- Always verify NDC, lot number, and expiration date before dispensing or consuming any medication.
- Ask your pharmacist about any recalls on prescribed medications.
- Register recall updates with your pharmacy or healthcare provider to receive immediate notifications.
Documentation advice
Retain Recall notification, original packaging, and all correspondence. Photograph the packaging and vial label for records.
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Product Details
NDC 67877-514-90 (90-count) and NDC 67877-514-05 (500-count). Manufacturer: Alkem Laboratories, Ltd. India. Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. Generic: Atorvastatin Calcium. Brand: Atorvastatin Calcium. Distribution: U.S. Nationwide. Recall date: 2025-09-19. Status: Active.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 90-count and 500-count packages
- Country of manufacture: India
- Distribution: Nationwide in the U.S.
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Safety Guide
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