Ascend Recalls Atorvastatin 80mg Due to Dissolution Failure
Ascend Laboratories recalls specific lots of Atorvastatin Calcium Tablet USP 80 mg due to failed dissolution specifications. Check your bottle's NDC and lot number.
Use caution until it’s fixed
Failed Dissolution Specifications
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What happened, in plain English
Ascend Laboratories, LLC is recalling specific bottles of Atorvastatin Calcium Tablet USP 80 mg because the tablets failed to meet dissolution specifications. This means the medication may not release its active ingredient properly in the body, potentially reducing its effectiveness for patients who rely on it. The recall covers both 90-count and 500-count prescription bottles distributed to wholesalers across the United States. Read more at govinfonow.com/recall/38263-ascend-recalls-atorvastatin-80mg-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/38263-ascend-recalls-atorvastatin-80mg-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-1515-2019
Cite this page
“Ascend Recalls Atorvastatin 80mg Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/38263-ascend-recalls-atorvastatin-80mg-due-to-dissolution-failure. Based on FDA recall #D-1515-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1515-2019%22&limit=1).
Why it’s dangerous
The hazard is that the tablets failed dissolution specifications, which is a quality control measure ensuring the drug breaks down and releases its ingredients as intended. If the medication does not dissolve correctly, patients may not receive the full therapeutic dose needed to manage their condition effectively.
Who’s affected
Patients currently taking Atorvastatin Calcium Tablet USP 80 mg prescribed by their doctors are affected. Individuals who purchased these specific bottles from wholesalers or pharmacies before the recall date may have the impacted product.
How to tell if you have this one
Check your bottle for NDC 67877-0514-90 (90 count) or NDC 67877-0514-05 (500 count). Verify the lot numbers and expiration dates: Lot# 19140443 (exp. 12/2020), Lots 19140525/19140535 (exp. 01/2021) for the 90-count bottles; and Lots 19140756 (exp. 12/2020), 19140757/19140758 (exp. 01/2021), 19141696/19141793 (exp. 03/2021) for the 500-count bottles.
- Brand
Ascend Laboratories- Category
Drug
What to do — step by step
Check Your Bottle
Compare your Atorvastatin bottle's NDC and lot numbers against the recalled list to see if it is included in this recall.
Contact Your Pharmacist
If you have a recalled bottle, contact your pharmacy or healthcare provider immediately for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was shipped to wholesalers throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1515-2019 (July 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1515-2019 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.