Valsartan, Losartan and Irbesartan Recalls: What MDL 2875 Shows

Valsartan, losartan and irbesartan are prescription medicines in the angiotensin II receptor blocker class. Valsartan is used to treat high blood pressure and heart failure, and the other two belong to the same class. Beginning in July 2018, manufacturers recalled many lots of these products after FDA testing found nitrosamine impurities in the active ingredient or the finished tablets. Federal lawsuits over the recalls are consolidated as MDL No. 2875 in the District of New Jersey. The Judicial Panel on Multidistrict Litigation reports 1,426 actions pending of 1,649 filed as of October 1, 2026. The court orders and agency records reviewed here contain no finding that a recalled product caused any individual’s cancer, and no approved settlement.

What is established versus what is alleged

The regulatory record is established. The FDA announced on July 13, 2018 that certain batches of valsartan tablets were being recalled because of an impurity called N-nitrosodimethylamine, or NDMA. The agency’s page on the recall states that valsartan is commonly used to treat high blood pressure and heart failure, and that NDMA has been found to increase the occurrence of cancer in animal studies at doses much higher than the impurity levels in the recalled batches. It also notes that the Environmental Protection Agency considers NDMA a probable human carcinogen.

The scope of the recalls is established in the agency’s own records. The FDA’s page on angiotensin II receptor blocker recalls lists updates through 2019 covering all three drugs. It records that FDA and international regulators identified NDMA, N-nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in these products. A search of the agency’s enforcement reports returns 138 records for products described as valsartan, 117 for losartan and 31 for irbesartan. Many concern separate strengths or lots of one recall, so the counts are not counts of separate events.

What remains alleged is the connection between the recalls and individual harm. The master complaints in the MDL assert claims for personal injury, economic loss and medical monitoring. The complaints allege that the defendants manufactured or supplied contaminated products, failed to warn or oversee their supply chains, and caused injury or costs. A complaint is an allegation, not evidence, and no document reviewed here treats it as a finding.

What the FDA found and what it recalled

The FDA’s page gives the sequence. The July 2018 announcement concerned valsartan. Later updates describe recalls of losartan made with active ingredient from Hetero Labs after testing found NMBA, and recalls of irbesartan after testing found NDEA. The page records the agency’s interim limits for nitrosamines in these drugs. In a March 20, 2019 update, the agency said it would not object to manufacturers temporarily distributing losartan containing NMBA above the interim limit of 0.96 parts per million and below 9.82 parts per million while the impurity was eliminated, a step it said was needed to maintain supply.

On October 15, 2019, the FDA posted a warning letter to Torrent Pharmaceuticals concerning manufacturing practice violations at a facility in Gujarat, India. On November 13, 2019, it posted a warning letter to Mylan Pharmaceuticals concerning its valsartan active ingredient facility in Andhra Pradesh. A warning letter is a regulatory action. It is not a court finding of liability, and it does not establish that any person was harmed.

The agency’s general page on nitrosamine impurities explains the risk assessment behind the recalls. It states that nitrosamines may increase the risk of cancer if people are exposed above acceptable levels over long periods, but that a person taking a drug containing nitrosamines at or below the limits every day for 70 years is not expected to have an increased risk of cancer. The page tells patients not to stop taking prescription medicines with potential nitrosamine impurities and to talk to their health care professionals about concerns.

Where the federal litigation stands

The actions were consolidated in 2019 as MDL No. 2875. Case Management Order No. 1, entered February 25, 2019, directed the clerk to maintain a master docket captioned In re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation, D.N.J. Civil Action No. 19-2875. The court’s MDL page lists master docket 1:19-md-2875, Chief Judge Renee Marie Bumb and Magistrate Judge Sharon A. King. The Panel’s October 1, 2026 report lists Chief Judge Bumb as transferee judge and 1,426 actions pending of 1,649 filed.

On January 12, 2021, Judge Robert B. Kugler entered MTD Opinion 2, which addressed Article III standing to bring the three master complaints. The court held that the economic loss complaint adequately alleged injury in fact on two theories, receipt of a worthless product and the cost of replacement medication, and that the medical monitoring complaint adequately alleged injury from exposure to carcinogens. It also held that plaintiffs had not traced their injuries to numerous named manufacturer, wholesaler and pharmacy defendants, and dismissed claims under the laws of 31 states and territories where no named plaintiff resided. The opinion concluded: “Defendants’ Motions to Dismiss are GRANTED in part. Plaintiffs have up and including 27 January 2021 to move to amend.”

On October 29, 2021, Special Master Thomas I. Vanaskie issued Special Master Order No. 51. The order recommended dismissal with prejudice of medical monitoring claims against Torrent Pharmaceuticals, Ltd., Torrent Pharma, Inc., Albertson’s, LLC, Humana Pharmacy, Inc., the Kroger Co., OptumRx and Arrow Pharma Malta. It also recommended dismissal with prejudice of economic loss claims against Humana Pharmacy and Arrow Pharma Malta. Those are special master recommendations, not a final district court judgment, and the order does not reach the merits of any personal injury claim. The personal injury claims were not dismissed in either order.

Key dates

• July 13, 2018: the FDA announces the recall of certain valsartan tablets because of NDMA (FDA ARB recall page).
• February 25, 2019: Case Management Order No. 1 establishes master docket 19-2875 and the MDL caption (CMO No. 1).
• March 20, 2019: the FDA says it will not object to temporary distribution of losartan with NMBA up to 9.82 ppm while the impurity is eliminated (FDA ARB recall page).
• October 15 and November 13, 2019: the FDA posts warning letters to Torrent Pharmaceuticals and Mylan Pharmaceuticals over manufacturing practice (FDA ARB recall page).
• January 12, 2021: the court grants in part the motions to dismiss the master complaints on standing grounds (MTD Opinion 2).
• October 29, 2021: the special master recommends dismissal with prejudice of specified medical monitoring and economic loss claims (Special Master Order No. 51).
• October 1, 2026: the Panel reports 1,426 actions pending of 1,649 filed in MDL No. 2875 (JPML statistics report).

What this does not establish

Nothing in the documents reviewed here shows a court finding that valsartan, losartan or irbesartan caused any individual’s cancer or other injury, that any defendant is liable, or that any reader is entitled to compensation. A recall is a regulatory action taken to remove products from the market. It is not a judicial determination that the product caused harm.

The record reviewed also contains no trial verdict in MDL No. 2875 and no final approval of a settlement. A pending count measures how many actions remain open. It does not show how actions that are no longer pending were resolved, and it does not measure the strength of any claim. Anyone taking one of these medicines should follow the FDA’s advice and speak with a health care professional rather than stopping a prescribed medicine because of a recall notice.

Frequently asked questions

Were valsartan, losartan and irbesartan recalled?

Yes. The FDA’s recall page records recalls of all three drugs beginning in 2018, and the enforcement database contains records for each. The recalls covered particular lots and strengths, not every product with these ingredients.

What impurities were found?

The FDA and international regulators identified NDMA, NDEA and NMBA in affected products. The agency set interim acceptable intake limits and recommended recall of products that tested above them.

Is there a settlement in MDL No. 2875?

The documents reviewed contain no court-approved settlement and no final approval order. The docket has produced pretrial rulings, including the January 12, 2021 standing decision and the October 29, 2021 special master recommendations, but those do not resolve the litigation.

Does a recall mean the drug caused cancer?

No. A recall reflects a regulatory judgment that a product contained an impurity above an acceptable level. It is not a finding that any particular person’s illness was caused by the product. Questions about an individual’s health belong with a clinician.

Who oversees the federal litigation?

The Panel’s October 1, 2026 report lists Chief Judge Renee M. Bumb as the transferee judge in the District of New Jersey. The court’s MDL page lists Magistrate Judge Sharon A. King and master docket 1:19-md-2875.

Background on related litigation appears in the pharmaceutical lawsuits section, including the proton pump inhibitor litigation, the GLP-1 litigation and the Zantac litigation.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by Actions Pending, Report Date 10/1/2026” (link, accessed 2026-10-19)
2. U.S. District Court for the District of New Jersey: “Valsartan MDL 2875” (link, accessed 2026-10-19)
3. U.S. District Court for the District of New Jersey: “MDL Case Management Order No. 1, In re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation, No. 19-2875 (D.N.J. February 25, 2019)” (link, accessed 2026-10-19)
4. U.S. District Court for the District of New Jersey: “MTD Opinion 2, In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation, MDL No. 2875 (D.N.J. January 12, 2021)” (link, accessed 2026-10-19)
5. U.S. District Court for the District of New Jersey: “Special Master Order No. 51 with Recommendations, In re: Valsartan N-Nitrosodimethylamine (NDMA) and Irbesartan Products Liability Litigation, MDL No. 2875 (D.N.J. October 29, 2021)” (link, accessed 2026-10-19)
6. U.S. Food and Drug Administration: “FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)” (link, accessed 2026-10-19)
7. U.S. Food and Drug Administration: “Information about Nitrosamine Impurities in Medications” (link, accessed 2026-10-19)
8. U.S. Food and Drug Administration, openFDA: “Drug Enforcement Report query: products described as valsartan” (link, accessed 2026-10-19)
9. U.S. Food and Drug Administration, openFDA: “Drug Enforcement Report query: products described as losartan” (link, accessed 2026-10-19)
10. U.S. Food and Drug Administration, openFDA: “Drug Enforcement Report query: products described as irbesartan” (link, accessed 2026-10-19)

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