Icosapent Ethyl and Rosuvastatin Injury Lawsuit Lawyers

Cholesterol Medication Recall Lawsuit: Icosapent Ethyl and Rosuvastatin Recall Raises Safety and Treatment Concerns.

Two separate nationwide prescription drug recalls involving cholesterol-related medications have raised concerns for patients who rely on consistent dosing to manage cardiovascular risk. One recall involves Icosapent Ethyl capsules, 1 gram, distributed in 120-count bottles. The other involves Rosuvastatin Tablets, USP, 10 mg, packaged in 50-tablet unit dose cartons. Both recalls were reported as voluntary actions tied to quality problems that can affect how the medications perform.

When a prescription medication is recalled for quality defects, the concern is not simply whether the pills or capsules “work.” The larger issue is that patients and prescribers make treatment decisions based on a reasonable expectation of consistency. A medication that is weaker than intended, or that does not dissolve properly, can interfere with therapy goals, create confusing lab results, and lead patients and doctors to make changes based on faulty assumptions.

For people who take cholesterol medications to reduce triglycerides, improve lipid profiles, or lower cardiovascular risk, treatment stability matters. Many patients taking these drugs have other risk factors, including hypertension, diabetes, prior cardiac events, or a family history of cardiovascular disease. A product defect that reduces effectiveness may increase the likelihood of complications, and it may also cause unnecessary medication changes, additional testing, and increased healthcare costs.

Recall 1: Icosapent Ethyl Capsules, 1 Gram (120-Count Bottles)

According to FDA recall reporting, Zydus Pharmaceuticals (USA) Inc. initiated a recall involving 22,896 bottles of Icosapent Ethyl capsules, 1 gram, distributed in 120-count bottles.

Why the product was recalled

The stated reason for the recall was subpotency caused by oxidation from leakage. The concern described is that leakage can lead to oxidation and reduced potency, which can result in inconsistent therapeutic effects and may increase the likelihood of certain side effects, including gastrointestinal side effects.

Affected lots and expiration dates

FDA-reported coverage indicates the affected lots include:

• S2520304 (expiration in 2027)
• S2520333 (expiration in 2027)
• S2540186 (expiration in 2027)

Why “subpotency” can matter for patients

Subpotency means the medication may deliver less active ingredient than intended. That can be especially serious when patients rely on stable, long-term therapy to meet lipid management targets. A product that performs inconsistently can lead to:

• Less predictable treatment response.
• Changes in laboratory values that do not reflect the patient’s true health status.
• Unnecessary dose changes or medication switches.
• Added appointments, bloodwork, and costs.
• Frustration and confusion for patients trying to follow a treatment plan.

Even if a patient does not feel immediate symptoms, the potential impact of underdosing can still be significant over time.

Recall 2: Rosuvastatin Tablets, USP, 10 mg (Unit Dose Cartons)

A separate FDA recall report involves AvKARE and Rosuvastatin Tablets, USP, 10 mg, packaged in 50-tablet unit dose cartons.

Why the product was recalled

The recall report states the product was out of specification for dissolution. In practical terms, dissolution relates to whether a tablet breaks down and releases the active ingredient properly in the body. When dissolution testing is out of specification, the concern is that the medication may not perform as expected, which can affect therapeutic results.

Affected lot and expiration date

FDA-reported coverage identifies:

• Lot 49124
• Expiration date: December 31, 2026

Why dissolution problems can affect safety and outcomes

If a tablet does not dissolve properly, a patient may not absorb the medication as intended. For some patients, that can mean:

• Reduced lipid-lowering effect.
• Unstable cholesterol levels despite adherence.
• Increased likelihood of treatment adjustments that may not have been necessary.
• Delays in achieving treatment goals.

For high-risk patients, delays or disruptions in effective therapy can have real consequences.

Why Medication Recalls Can Cause Harm Even Without “Classic” Side Effects

Many patients hear “recall” and think only about contamination or immediate toxicity. Quality recalls, such as subpotency and dissolution failures, can also cause harm, but the harm may look different.

Common downstream effects include:

Treatment instability

Patients and providers may interpret lab results as evidence that the medication is not working when the real problem is the product’s quality defect.

Avoidable medical expenses

Extra visits, repeat lab work, and medication changes can create costs that would not have occurred with a properly manufactured product.

Increased health risk for vulnerable patients

Patients with cardiovascular disease, diabetes, metabolic syndrome, or prior heart events are often placed on medication regimens designed to reduce risk over time. Inconsistent performance can undercut those goals.

Emotional strain and loss of trust

People managing chronic conditions often work hard to follow instructions. Learning that a prescribed medication may have been defective can create anxiety and distrust, especially when health outcomes are on the line.

What Patients Should Do If They Have One of the Recalled Medications

A recall notice can be unsettling, but the next steps should be careful and organized.

Step 1: Confirm the exact product details

Check the bottle or carton for:

• medication name and strength
• manufacturer or distributor information
• lot number
• expiration date

Step 2: Contact the dispensing pharmacy

A pharmacy can confirm whether the medication matches the recalled lot and can advise on replacement or return procedures.

Step 3: Contact the prescribing provider before changing therapy

Many cholesterol-related medications should not be stopped abruptly without a plan. A prescriber can advise how to transition safely to replacement medication or an alternative.

Step 4: Document what happened

If a patient experienced worsening lab results, new symptoms, adverse effects, or medical interventions connected to the recalled medication, documentation can matter later. Useful items include:

• photos of labels showing lot numbers
• pharmacy receipts
• medical visit summaries
• lab results over time
• communications with healthcare providers

Potential Legal Claims After a Prescription Drug Recall

Not every recall leads to a lawsuit. However, when a recalled medication is linked to patient harm, avoidable medical costs, or worsening health outcomes, legal claims may be considered depending on the facts and the law of the state involved.

Common legal theories in medication recall cases can include:

Product liability

Claims may allege a defect in manufacturing, packaging, or quality control that caused the medication to perform incorrectly.

Negligence

Claims may focus on whether reasonable care was used in manufacturing, testing, packaging, storage, or distribution.

Failure to warn

In some cases, litigation examines whether adequate warnings or timely recall actions were taken once a defect was identified.

The key questions typically include what defect occurred, how it affected performance, whether it caused harm, and what damages resulted.

Who May Qualify for a Prescription Recall Lawsuit

Eligibility depends on facts, but people who often warrant legal review include:

• Patients who took the recalled medication and later required medical intervention were tied to reduced effectiveness.
• Patients whose lab results changed substantially while taking the recalled lot, leading to additional testing or treatment changes.
• Patients who experienced complications after therapy destabilization.
• Families facing losses after a serious cardiovascular event, where medication performance becomes a meaningful issue.

A legal review typically looks at timing, documentation, diagnosis history, and whether damages can be connected to the recall defect.

Damages That May Be Recoverable

When a recalled medication causes measurable harm, damages may include:

• Costs of medical visits, testing, and follow-up care.
• Costs of replacement medication or additional prescriptions.
• Out-of-pocket expenses related to the recall and treatment changes.
• Lost income if complications required missed work.
• Pain, suffering, and emotional distress tied to health disruption.
• Wrongful death damages in the most severe cases, depending on state law.

The value of a claim depends on the severity of harm, the medical record, and the long-term effect on the patient’s health.

Icosapent Ethyl and Rosuvastatin Lawsuit FAQs

How do I know if my prescription is included in the recall?
Start with the label. For Icosapent Ethyl, look for the lot number and confirm whether it matches the affected lots reported in the recall. For Rosuvastatin 10 mg unit dose cartons, confirm the lot number and expiration date. A pharmacy can verify whether the dispensed product matches the recalled batch and can advise on replacement steps.

What does “subpotent” mean, and why is it important?
Subpotent means the medication may contain less active ingredient than intended or may not deliver the expected dose. For patients using lipid-related medications, an under-strength product can lead to inconsistent therapeutic effect, confusing lab results, and treatment changes that would not have been necessary with a properly manufactured drug.

What does “out of specification for dissolution” mean?
Dissolution testing evaluates whether a tablet breaks down and releases medication properly. If a tablet is out of specification, there is concern it may not dissolve as expected, which can change absorption and reduce effectiveness. Patients may not notice immediate symptoms, but therapy results can be affected over time.

Should the medication be stopped immediately?
Many patients should not stop a prescription medication without guidance. The safest approach is to contact the pharmacy and prescribing provider promptly to confirm whether the product is affected and to arrange a replacement or alternative therapy plan.

Can a recalled medication lead to a lawsuit even if there was no hospitalization?
Yes, in some situations. A claim can involve more than emergency injury. If the recall caused measurable losses such as repeated lab work, additional appointments, medication switches, out-of-pocket costs, or documented health decline tied to underperformance, those facts may warrant legal review.

What evidence helps support a claim?
Key evidence often includes the medication container or carton (showing lot number and expiration), pharmacy records, proof of purchase, medical records, lipid panels and other labs, and documentation of provider-directed treatment changes that occurred during the time the recalled medication was used.

Contact Parker Waichman LLP For a Free Case Review

A prescription medication recall can create serious medical uncertainty, added costs, and real health risks, especially for patients managing cardiovascular concerns. If a recalled cholesterol-related medication caused harm, treatment disruption, or significant out-of-pocket losses, legal options may be available.

Parker Waichman LLP is a national personal injury law firm that represents individuals harmed by defective products and unsafe pharmaceuticals. A free consultation is available to discuss what happened, review documentation, and explain potential next steps. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.

Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation.