Recall

Stop Clopez Corp voluntarily recalls herbal dietary supplement

April 26, 2024 - On April 23, 2024, the United States FDA published a voluntary recall from Stop Clopex Corp regarding its Schwinnng capsules. According to the recall, the product was found to contain Nortadalafil, an active drug ingredient, during an FDA analysis. Dietary supplements are only loosely regulated across the United States. Unlike pharmaceutical...

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Heart devices linked to injuries, deaths receive FDA’s most serious recall

by Alivia Kaylor

In a recent announcement, the Food and Drug Administration (FDA) revealed that a pair of heart devices, the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS), has received the agency's most serious recall...

Mislabeled Packaging Results in Recalled ADHD Medication

by Veronica Salib

On January 24, 2024, Azurity Pharmaceuticals sent an announcement to the United States FDA recalling Zenzedi, a brand name for 30 mg dextroamphetamine sulfate tablets, for mislabeled packaging. The...

Evaluating the Series of Infant Formula Recalls in the US

by Veronica Salib

Infant formula plays a critical role in pediatric healthcare, providing an alternate route for nutrition in babies who do not breastfeed or may need more nutrients than what is provided in breast milk. Although many people, including...

FDA Recalls 3 IV Drugs from Leiters Health for Potential Superpotency

by Veronica Salib

On January 5, 2024, the United States FDA published an announcement detailing a voluntary recall of multiple intravenous (IV) drugs manufactured by Leiters Health. The release notes that 33 lots of IV...

FDA Announces Kilitch Healthcare India Eyedrop Recall

by Veronica Salib

On November 15, 2023, the United States Food and Drug Administration published a voluntary recall statement from Kilitch Healthcare India Limited for 27 eyedrops distributed across the US through...

FDA Issues Warning Letter to Amazon with Concerns About Eye Drop Sales

by Veronica Salib

On November 13, 2023, the United States Food and Drug Administration (FDA) publicly published a warning letter issued to Andrew Jassy, CEO of Amazon.com, identifying violations in seven...

What to Know About the 2023 Eyedrop Recalls, Understanding the Risks

by Veronica Salib

On February 2, 2023, the first of three eyedrops in the United States were recalled voluntarily after multiple reports of illness associated with the drops were reported to the CDC. Since then, two additional eye drops in the US...

26 More Eyedrops Recalled from CVS, Target, Walmart, Rite Aid and More

by Veronica Salib

On October 27, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers to avoid using 26 over-the-counter eye drops sold under multiple brands, including CVS Health,...

FDA Updates Infant Formula Compliance Program

by Veronica Salib

To minimize the risk of contaminated infant formula, the United States Food and Drug Administration (FDA) updated its infant formula compliance program, announcing the changes on October 6, 2023. Last...

How Quality Assurance Shapes US Drug Manufacturing

by Alivia Kaylor

The world of pharmaceuticals stands as a cornerstone of modern medicine. Behind every pill, every capsule, and every syringe lies an intricate process of creation, where precision and excellence are non-negotiable. Drug manufacturing is a...

CDC Follows Listeria Outbreak After Ice Cream Recall

by Veronica Salib

On August 22, 2023, the Centers for Disease Control and Prevention published additional information on a Listeria outbreak linked to a recent food recall. Earlier that month, the United States Food and...

More Eyedrops Recalled Due to Bacterial, Fungal Contamination

by Veronica Salib

On August 22, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers on two methylsulfonylmethane (MSM) eyedrops, reporting bacterial and fungal contaminations as the...

Lupin Pharmaceuticals Recalls Two Lots of Birth Control

by Veronica Salib

On July 28, 2023, Lupin Pharmaceuticals, a manufacturer based out of Baltimore, MD, voluntarily recalled two lots of Tydemy. The drug is an estrogen and progestin oral contraceptive, also known as a...

Cipla Albuterol Sulfate Inhalation Aerosol Voluntarily Recalled

by Veronica Salib

On July 6, 2023, Cipla US recalled six batches of its albuterol sulfate inhalation aerosol, 90 mcg (200 MI). According to the release published by the FDA on July 7, 2023, the company cited a container...

FDA Adds Another Frozen Fruit to Recall List: Listeria Contamination

by Veronica Salib

On June 22, 2023, the Scenic Fruit Company issued a voluntary recall on frozen pineapple and fruit blends, including frozen pineapple, due to potential contamination with Listeria monocytogenes. This...

FDA Announce Additional Frozen Fruit Recall: Hepatitis A Contamination

by Veronica Salib

Last week, the FDA issued an announcement recalling multiple kinds of frozen fruit by Willamette Valley Fruit Co. The company is recalling the Great Value sliced strawberries, mixed fruit, and...

CDC Update Identifies Fourth Death Linked to Eyedrop Recall

by Veronica Salib

On May 19, 2023, the CDC released an update on the Pseudomonas aeruginosa outbreak linked to artificial tears from Global Pharma Healthcare. The report identifies a fourth death linked to the series of...

FDA Domestic and Foreign Oversight Protocols and Violation Responses

by Veronica Salib

The United States Food and Drug Administration (FDA) has been criticized repeatedly for shortcomings and flaws in its oversight protocols. Understanding the current regulations that the FDA follows for assessing drug manufacturing...

FDA Withdraws Approval of a Premature Birth Drug After 12 Years

by Veronica Salib

On April 6, 2023, the FDA Commissioner Robert M. Califf, MD, and Chief Scientist Namandjé Bumpus, PhD, announced the organization’s decision to withdraw the approval of Makena...

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