What is being recalled?

Atorvastatin Calcium Tablets USP, 80 mg in 90-count and 500-count packages distributed by Ascend Laboratories are recalled due to failed dissolution specifications.

Why is this recall issued?

The tablets failed dissolution specifications, which may affect how the drug releases in the body and could impact dosing consistency.

Which lots are affected?

Affected lots include various Lot numbers such as 25140249 and others with expiration dates in 2026, listed in the recall notice.

How do I know if my product is recalled?

Check the packaging for the NDCs 67877-514-90 or 67877-514-05 and the specific Lot numbers and expiration dates shown in the recall.

What should I do if I have recalled tablets?

Stop using the product immediately and contact Ascend Laboratories or your healthcare provider for guidance on next steps.

Is there a refund or replacement available?

The recall notes that refunds or replacements may be provided; contact Ascend Laboratories for instructions.

How long will refunds take?

The recall notice does not specify timelines; consumers should follow instructions provided by Ascend Laboratories.

What if I have questions or need more information?

Consult your healthcare provider or contact Ascend Laboratories for official guidance and recall updates.

Can this affect pregnancy or other health conditions?

This recall concerns dissolution performance of a cholesterol-lowering medication. Discuss implications with a prescriber if you are pregnant or have specific health conditions.

Where can I find the official recall notice?

FDA enforcement page listing enforcement report D-0020-2026 contains the official recall details.

HIGHSeptember 19, 2025

Ascend Laboratories Recalls Atorvastatin Calcium 80 mg Tablets (90-Count & 500-Count) for Failed Dil

Ascend Laboratories recalls Atorvastatin Calcium Tablets USP, 80 mg, in 90-count and 500-count packages nationwide. The recall cites failed dissolution specifications. Health care providers and patients should stop using the recalled tablets and seek guidance from Ascend or their prescribers.

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

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 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.

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

2 NDCs: 67877-514-90 and 67877-514-05
90-count and 500-count packages
Country of manufacture: India
Distribution: Nationwide in the U.S.
Recall date: 2025-09-19
Status: Active

View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeAtorvastatin Calcium Tablets 80 mg

Product Details

Brand

Ascend Laboratories

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