FDA Recalls 141,984 Bottles of Atorvastatin Calcium After Failed Dissolution Testing

On 10 October 2025 the U.S. Food and Drug Administration (FDA) classified a nationwide recall of Atorvastatin Calcium tablets, initiated by Ascend Laboratories, LLC, as a Class II recall because multiple lots “failed dissolution specifications,” affecting 141,984 bottles distributed across the United States. The recalled product is a generic formulation of atorvastatin (a statin widely used to reduce low‑density lipoprotein cholesterol and cardiovascular risk), manufactured by Alkem Laboratories, Ltd. (India) and distributed by Ascend Laboratories (Parsippany, NJ).

What the recall means 

• Recall classification: Class II — the product “may cause temporary or medically reversible adverse health consequences” while serious adverse outcomes are considered remote.
• Root cause reported: Failure to meet dissolution specifications during quality testing. Dissolution testing assesses how quickly and completely a solid oral dosage form releases the active pharmaceutical ingredient under standardized in vitro conditions; failure may reduce systemic bioavailability and thus clinical effectiveness.
• Scale: 141,984 bottles across multiple strengths (10 mg, 20 mg, 40 mg, 80 mg) and container sizes (90-, 500-, 1,000-count) with expiration dates ranging from mid‑2026 to February 2027.

Affected products (concise table)

Strength	Bottle sizes	Typical NDC prefix	Representative lot ranges	Expiration range
10 mg	90, 500, 1,000 count	67877-511	Multiple lots (e.g., 25141249; 24144938)	July 2026–Feb 2027
20 mg	90, 500, 1,000 count	67877-512	Multiple lots (e.g., 25140150; 24144720)	June 2026–Dec 2026
40 mg	90, 500, 1,000 count	67877-513	Multiple lots (e.g., 25140933; 24144254)	Sep 2026–Feb 2027
80 mg	90, 500 count	67877-514	Multiple lots (e.g., 25140249; 24144999)	Aug 2026–Dec 2026

Source: FDA enforcement report.

Clinical and public‑health implications

Atorvastatin is one of the most commonly prescribed statins in the U.S.; estimates indicate tens of millions of adults take statins for primary and secondary prevention of atherosclerotic cardiovascular disease. When a tablet fails dissolution testing, the principal concern is suboptimal absorption of the active drug in vivo, which can reduce LDL‑cholesterol lowering and attenuate the protective benefits against myocardial infarction and stroke over time if many doses are under‑delivering active drug.

However, the FDA’s Class II designation and standard regulatory guidance indicate that while the dissolution failure represents a significant quality issue, the likelihood of acute, severe toxicity is low; the primary risk is reduced efficacy rather than direct harm from an impurity or contamination event. Clinical management should therefore focus on ensuring continued lipid control rather than immediate emergency interventions for asymptomatic patients.

Recommended actions for patients and clinicians

• Check medication labels: Compare the NDC, lot number, strength, and expiration date on any atorvastatin bottles with the affected lot lists published by the FDA.
• Do not stop statin therapy without clinical advice: Stopping statins abruptly can increase short‑term cardiovascular risk in some patients; decisions should be individualized and made with the prescribing clinician.
• Contact pharmacist or prescriber: If your bottle is on the affected list, contact your pharmacist or healthcare provider to obtain guidance on replacement supply or therapeutic substitution. Pharmacies often have access to non‑affected lots and generics from alternate manufacturers.
• Report quality issues or adverse events: Use the FDA MedWatch reporting system to document any product quality issues or suspected treatment failures related to the recalled lots.

Recall History

The recall was initiated by the distributor Ascend Laboratories on 19 September 2025 and appears to apply to lots manufactured overseas (Alkem Laboratories, India) and distributed nationwide by Ascend/Ascend Laboratories, LLC. Media coverage and health outlets have summarized the FDA enforcement report and advised consumers to verify lot numbers and consult clinicians or pharmacists for next steps. As of the FDA entry, Ascend had not issued a separate press release; the FDA enforcement report remains the primary authoritative source of lot and product detail.

What to watch next

• Replacement lots and supply management: Pharmacies and health systems will need to confirm inventory and source unaffected atorvastatin supplies to avoid lapses in therapy for patients at high cardiovascular risk.
• Regulatory follow‑up: The FDA may require corrective and preventive actions from the manufacturer, including investigation into manufacturing process controls, dissolution method validation, and potential root‑cause analysis and remediation. Class II recalls typically trigger follow‑up inspections and submission of remediation plans to the agency.

Clinical outcome surveillance: Clinicians and public‑health entities may monitor lipid control metrics or adverse cardiovascular events in populations who received recalled lots, particularly where large doses or long refill supplies (500–1,000 count bottles) were dispensed.