Tainted valsartan, which has been the subject of FDA recalls, has sparked a class action lawsuit against the drug’s manufacturers and packagers.

On Oct. 25, plaintiff Ron Molinaro filed a lawsuit against Solco Healthcare U.S. LLC and Huahai US Inc., alleging that the companies were responsible for tainted valsartan reportedly containing a possible carcinogen.

Valsartan is a drug ingredient used in medications for the treatment of hypertension, heart failure, and other conditions. The active ingredient is made by Huahai, a China-based pharmaceutical company, and distributed in the United States by subsidiary Solco Healthcare.

In July, the U.S. Food and Drug Administration (FDA) announced that several manufacturers were recalling their products which used Huahai tainted valsartan. The FDA stated that the tainted valsartan in question contained an impurity, N-nitrosodimethylamine (NDMA). NDMA is a substance which the FDA classifies as a probable human carcinogen.

Although the FDA’s ongoing recall affects products distributed as early as October 2015, Molinaro alleges in his tainted valsartan class action that it was possible that products manufactured as early as 2012 were also contaminated with NDMA.

“[F]or years, defendants willfully ignored warning signs regarding the operating standards at the Zhejiang Huahai Pharmaceuticals manufacturing plant in China and continued to allow ZHP to manufacture their valsartan products for sale to consumers in the United States, even after defendants knew or should have known that their valsartan products manufactured by ZHP contained or likely contained NDMA and/or other impurities,” the tainted valsartan class action lawsuit alleges.

Molinaro’s complaint includes claims for breach of warranties, fraud, unjust enrichment, negligence, and violation of Florida’s Deceptive and Unfair Trade Practices Act.

In late October, U.S. District Judge Shero Polster tossed the valsartan lawsuit, finding that Molinaro hadn’t provided sufficient information regarding the involved parties. The lack of information reportedly meant that the court could not determine that the case belongs in federal court under the Class Action Information Act.

“Because the complaint lacks the [needed] allegations, the court cannot determine whether the parties are minimally diverse,” Judge Polster wrote.

However, Judge Polster gave the opportunity for Molinaro to amend his complaint and refile. Plaintiff counsel has confirmed with Law360 that they will be filing an amended complaint in the future.

Solco Healthcare did not comment to Law360 on the recent valsartan lawsuit. However, their Aug. 21 statement regarding the tainted valsartan denied allegations that contamination may have been discovered by the FDA years ago. The company maintains that the impurities were discovered in June in an internal review.

“After further analyses and confirmations, regulatory authorities were notified promptly and recall actions were voluntarily initiated by the company for the remaining [valsartan] in the company’s and its customers’ inventories,” said a Solco Healthcare statement.

The Valsartan Class Action Lawsuit is Molinaro v. Prinston Pharmaceutical Inc. et al., Case No. 2:18-cv-710, in the U.S. District Court for the Middle District of Florida.