What is being recalled?

Alkem Atorvastatin Calcium Tablets USP 20 mg, in 90-count, 500-count and 1000-count packages, distributed by Ascend Laboratories. The recall is due to failed dissolution specifications.

Are these products safe to take?

No. Healthcare providers and patients should stop using the recalled tablets and contact Ascend Laboratories or a healthcare provider for guidance.

How can I tell if my product is affected?

Check the bottle label for the NDC codes 67877-512-90, 67877-512-05, or 67877-512-10.

What should I do if I have an affected lot?

Discontinue use and follow the recall instructions provided by Ascend Laboratories. Contact your healthcare provider for alternatives.

Will I get a refund or replacement?

Refunds or replacements are managed through Ascend Laboratories recall communications.

Where can I get more information?

Visit the FDA enforcement report page referenced in the recall notice for official updates.

What is the impact on patients with cardiovascular conditions?

Patients should consult their clinician for guidance on therapy substitutions or adjustments if they have concerns about dosing.

What if the product was prescribed by a doctor?

Contact the prescribing clinician to determine whether to continue therapy or switch to an alternative medication.

How long will the recall process take?

Recall timelines vary; follow the recall notices sent by Ascend Laboratories.

HIGHSeptember 19, 2025

Ascend Laboratories Recalls Alkem Atorvastatin Calcium 20 mg Tablets for Dissolution Failures (3 NDC

Q: Who manufactured and distributed the recalled product?

Manufactured by Alkem Laboratories, Ltd. India. Distributed by Ascend Laboratories, LLC, Parsippany, NJ.

Ascend Laboratories recalls Alkem Atorvastatin Calcium Tablets USP 20 mg for dissolution failures in 2025. Distributed by Ascend Laboratories, Parsippany, NJ, nationwide. The issue: dissolution specifications not met. Stop use immediately and follow recall instructions. Check your NDC numbers to identify affected lots.

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

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 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

Identify NDC codes on the packaging: 67877-512-90, 67877-512-05, 67877-512-10
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

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

NDC 67877-512-90
NDC 67877-512-05
NDC 67877-512-10
Distributed nationwide in the U.S.
Hazard: Dissolution specification failures
Active recall as of 2025-10-22

View Original Recall on FDA - Drug Safety

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERALPREGNANT

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypePrescription statin tablet

Product Details

Brands

Ascend Laboratories Alkem Laboratories

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