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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Atorvastatin Calcium Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: August 2, 2019
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Summary

Ascend Laboratories LLC is recalling approximately 11,352 bottles of Atorvastatin Calcium Tablets (80 mg), a cholesterol-lowering medication, including both 90-count and 500-count bottles. The recall was initiated because the tablets failed dissolution specifications, meaning the medication may not dissolve properly in the body as intended. This could potentially reduce the drug's effectiveness in managing cholesterol levels. These prescription medications were manufactured by Alkem Laboratories in India and distributed to wholesalers throughout the United States.

Risk

If the medication fails to dissolve correctly, the active ingredient may not be absorbed into the bloodstream at the required rate, which could lead to poorly controlled cholesterol levels and a potential increase in cardiovascular risk over time.

What You Should Do

  1. Check your Atorvastatin Calcium 80 mg prescription bottles for the following NDC numbers: 67877-0514-90 (90-count) or 67877-0514-05 (500-count).
  2. If you have a 90-count bottle, check for Lot# 19140443 (Exp. 12/2020) or Lot numbers 19140525 and 19140535 (Exp. 01/2021).
  3. If you have a 500-count bottle, check for Lot# 19140756 (Exp. 12/2020), Lot numbers 19140757 and 19140758 (Exp. 01/2021), or Lot numbers 19141696 and 19141793 (Exp. 03/2021).
  4. Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking your current supply or obtain a replacement prescription; do not stop taking prescribed cholesterol medication without professional guidance.
  5. Return any unused tablets from the affected lots to your pharmacy for a refund and contact Ascend Laboratories LLC at their Parsippany, NJ headquarters if you have further questions.
  6. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmaceutical guidance and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Atorvastatin Calcium Tablet USP 80 mg (90 count bottle)
Model:
NDC 67877-0514-90
Recall #: D-1515-2019
Lot Numbers:
19140443 (Exp. 12/2020)
19140525 (Exp. 01/2021)
19140535 (Exp. 01/2021)
Date Ranges: 12/2020, 01/2021
Product: Atorvastatin Calcium Tablet USP 80 mg (500 count bottle)
Model:
NDC 67877-0514-05
Recall #: D-1515-2019
Lot Numbers:
19140756 (Exp. 12/2020)
19140757 (Exp. 01/2021)
19140758 (Exp. 01/2021)
19141696 (Exp. 03/2021)
19141793 (Exp. 03/2021)
Date Ranges: 12/2020, 01/2021, 03/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83378
Status: Resolved
Manufacturer: Ascend Laboratories LLC
Sold By: wholesalers
Manufactured In: India, United States
Units Affected: a) 5,472 bottles and b) 5,880 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.