Ascend Recalls Atorvastatin 80mg Due to Failed Dissolution
Ascend Laboratories recalls specific lots of Atorvastatin Calcium Tablets USP, 80 mg due to failed dissolution specifications. Check your lot numbers.
Use caution until it’s fixed
Failed Dissolution Specifications
Contact the company
What happened, in plain English
Ascend Laboratories, LLC is recalling specific lots of Atorvastatin Calcium Tablets USP, 80 mg because they failed dissolution specifications. This means the tablets may not break down properly in the body, potentially affecting how well the medication works. The record does not specify a remedy or what consumers should do with these tablets. Read more at govinfonow.com/recall/31775-ascend-recalls-atorvastatin-80mg-due-to-failed-dissolution.
Source Summary by GovInfoNow · govinfonow.com/recall/31775-ascend-recalls-atorvastatin-80mg-due-to-failed-dissolution · Updated October 9, 2026 · FDA enforcement record: FDA #D-0020-2026
Cite this page
“Ascend Recalls Atorvastatin 80mg Due to Failed Dissolution.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31775-ascend-recalls-atorvastatin-80mg-due-to-failed-dissolution. Based on FDA recall #D-0020-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0020-2026%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, which is a quality control measure ensuring the drug releases at the right rate. If the tablets do not dissolve correctly, the body may not absorb the full dose of atorvastatin, leading to reduced effectiveness in treating high cholesterol.
Who’s affected
Consumers who have purchased Atorvastatin Calcium Tablets USP, 80 mg distributed by Ascend Laboratories, LLC in the U.S. nationwide between the manufacture date and the expiration dates listed. Individuals relying on this specific dosage for cholesterol management are most at risk of receiving ineffective medication.
How to tell if you have this one
Check your bottle for the brand 'Ascend Laboratories' and the strength '80 mg'. Verify the National Drug Code (NDC) is either 67877-514-90 (90-count) or 67877-514-05 (500-count). Check the lot number against this list: 25140249, 25140247, 24144999, 24144942, 24144845, 24144713, 24144652, 24143898, 24143412, or 24143582.
- Brand
Ascend Laboratories- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S. Nationwide- NDC
67877-511-90, 67877-511-05, 67877-511-10, 67877-511-55, 67877-511-33, 67877-511-38, 67877-512-90, 67877-512-05, 67877-512-10, 67877-512-44, 67877-512-33, 67877-512-38, 67877-513-90, 67877-513-05, 67877-513-10, 67877-513-23, 67877-513-33, 67877-513-38, 67877-514-90, 67877-514-05, 67877-514-10, 67877-514-33, 67877-514-38
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0017-2026 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.; Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026 | 141,984 bottles |
| D-0018-2026 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.; Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026 | — |
| D-0019-2026 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.; Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July 2026 | — |
| D-0020-2026 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054; 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, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026 | — |
What to do — step by step
Check Your Lot Number
Compare the lot number on your bottle against the recalled list provided in the recall record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have the affected product and what alternative treatment options are available.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0020-2026 (September 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0020-2026 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.