Dozens of Generic Medications Recalled Due to Quality Issues

Affected drugs treat common conditions, including heart disease, high cholesterol, diabetes

AARP

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Published April 17, 2025

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This article was created with the assistance of generative AI. It was reviewed by editors before publication.

Glenmark Pharmaceuticals Inc. has voluntarily recalled nearly 40 types of generic medications after U.S. regulators found problems with how the drugs were manufactured at a facility in India, the Food and Drug Administration (FDA) announced.

The recall stems from violations of the FDA’s Current Good Manufacturing Practice (CGMP) standards—rules that ensure medications are made safely and consistently.

The recall is classified as Class II, which the FDA defines as a product that could cause temporary or medically reversible health effects or where there is a low risk of serious harm.

What are CGMP deviations?

The medications were cited for CGMP deviations, which means the company failed to comply with the FDA's regulations for manufacturing practices, affecting the quality and safety of medications, potentially leading to adverse health effects.

Though everyone is exposed to some risk from manufacturing deviations, the FDA sets strict guidelines to ensure medications are produced safely and effectively to minimize health risks.

Advice to consumers

Patients using the recalled medications are advised to continue their treatment and contact their pharmacist, physician, or medical provider to discuss alternative options.

Consumers with questions regarding this recall should contact Glenmark Pharmaceuticals Inc. at 877-538-8445 between 9 a.m. and 5 p.m. EST Monday through Friday.

Negative reactions or quality issues resulting from use of recalled items may also be reported to the FDA’s MedWatch adverse event reporting program.

Recalled medications

The recalled medications are used to treat a variety of common conditions, including heart disease, high cholesterol, diabetes, epilepsy, psychiatric disorders, and various types of pain and infections. They are:

Acetaminophen and Ibuprofen (NSAID) tablets 250 mg/125 mg – 144-count and 216-count packets, sold by Walmart and Amazon

Lot Numbers: 17241302, 17241140, 17241141
Expiration Date: July 2026
Recall Number: D-0347-2025

Carvedilol tablets USP 12.5 mg – 500-count bottle

Lot Numbers: 17240238, 17240243, 17240245, 17240248
Expiration Date: January 2026
Recall Number: D-0336-2025

Cetirizine Hydrochloride tablets, USP, 10mg, 365-count packs, sold by Walmart and Amazon

Lot numbers: 17231980, 17232044, 17241436, 17241437, 17241455, 17241456, 17241457, 17241892, 17241893
Expiration dates: Aug-25, Jul-26, Aug-26, Oct-26
Recall Number: D-0348-2025

Clindamycin Hydrochloride capsules USP 300 mg – 100-count bottles