Memantine Hydrochloride

The Harvard Drug Group LLC has initiated a nationwide Class II recall for Memantine Hydrochloride Extended-Release Capsules due to failed dissolution specifications. This impacts the availability of a critical Alzheimer's treatment, necessitating immediate action from procurement and regulatory teams to assess supply chain risks and ensure patient safety. The recall highlights ongoing pharmaceutical quality control challenges.

Graviti Pharmaceuticals Private Limited has initiated a Class II recall for 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, due to failed tablet specifications. This impacts supply chains relying on the Hyderabad, India facility and its distributor, Rising Pharma Holdings, Inc. Procurement and regulatory teams must assess immediate supply risks and evaluate alternative generic Bupropion sources to mitigate disruption and ensure patient access.

Lupin Pharmaceuticals Inc. has initiated a Class II voluntary recall (D-0542-2025) for 7,668 bottles of Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg distributed nationwide in the US. The recall stems from a critical labeling error: products were released with an incorrect February 2027 expiration date instead of the correct January 2027. This event underscores the imperative for robust quality control in pharmaceutical labeling to mitigate supply chain disruptions and ensure patient safety.

Lupin Pharmaceuticals Inc. has voluntarily recalled 2,724 bottles of Clomipramine Hydrochloride Capsules USP 25 mg (Lot # M300464) due to out-of-specification degradation products. This Class II recall, initiated on June 27, 2025, and terminated on January 5, 2026, impacts nationwide distribution. Procurement and regulatory teams must assess immediate supply chain exposure and reinforce quality assurance protocols for generic antidepressants.

Eugia US LLC has initiated a Class II nationwide recall for 18,867 bags of Tirofiban Hydrochloride Injection due to out-of-specification results in stability studies for related substances. This event signals critical quality control deficiencies impacting a key cardiovascular drug. Procurement and regulatory teams must assess immediate supply chain risks and re-evaluate supplier qualification protocols to mitigate disruption and ensure patient safety.

Preferred Pharmaceuticals, Inc. has initiated a Class II recall for 1,190 bottles of Clindamycin Hydrochloride Capsules, USP, 300mg, manufactured by Glenmark Pharmaceuticals Limited. This nationwide US recall, stemming from cGMP deviations, necessitates immediate action from procurement and regulatory teams to assess supply chain integrity and ensure patient safety. The ongoing status highlights persistent compliance challenges within the pharmaceutical sector.

Glenmark Pharmaceuticals Inc., USA has initiated a U.S. nationwide Class II recall for specific lots of Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg due to Current Good Manufacturing Practice (CGMP) deviations at its Indian manufacturing facility. This event necessitates immediate action for procurement and supply chain leaders to assess inventory, ensure compliance, and mitigate potential supply disruptions for this critical cardiovascular medication.

A-S Medication Solutions LLC initiated a Class II recall for 411 bottles of Metformin Hydrochloride Extended-Release 500mg due to foreign tablets/capsules. This voluntary action, impacting nationwide U.S. distribution, signals critical quality control gaps for procurement and regulatory teams. Businesses must assess their supply chain exposure to A-S Medication Solutions and verify product integrity to mitigate patient safety risks and ensure compliance.

West-Ward Columbus Inc has initiated a Class III recall of 2,591 boxes of Methadone Hydrochloride Tablets, 5mg, due to illegible unit-dose identification. This event, distributed by Hikma Pharmaceuticals USA Inc., signals potential dispensing errors and adds to West-Ward's history of quality control issues, demanding immediate attention from procurement and regulatory teams to assess supply chain risks and ensure patient safety.

Glenmark Pharmaceuticals Inc., USA has initiated a Class II nationwide recall of 4,704 bottles of Diltiazem Hydrochloride Extended-Release Capsules due to cGMP deviations. The recall, D-0097-2025, stems from N-nitroso-Desmethyl-Diltiazem impurity levels exceeding FDA interim limits. This event underscores persistent nitrosamine risks and highlights critical cGMP compliance challenges for pharmaceutical manufacturers, impacting supply chain reliability and regulatory standing.

Zydus Pharmaceuticals USA Inc. initiated a Class II recall (D-0617-2024) for Venlafaxine Hydrochloride Extended-Release Capsules due to failed dissolution specifications. This voluntary action, impacting nationwide distribution, underscores critical quality control challenges for the manufacturer, Zydus Lifesciences Ltd. The recall is now terminated, but highlights ongoing regulatory scrutiny for generic extended-release formulations.

The Harvard Drug Group LLC dba Major Pharmaceuticals initiated a Class II recall for Venlafaxine Hydrochloride extended-release capsules due to failed dissolution specifications. This event, involving 864 cartons manufactured by Cadila Healthcare, highlights critical quality control vulnerabilities for procurement and regulatory teams. Decision-makers must reassess supplier oversight and product quality assurance protocols to mitigate supply chain disruptions and patient safety risks.

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall for 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, due to failed dissolution specifications. This nationwide recall, stemming from a long-term stability study, necessitates immediate action for procurement and supply chain leaders to mitigate disruption and ensure patient safety.

The Harvard Drug Group LLC initiated a Class II recall for HydrALAZINE Hydrochloride Tablets due to impurity issues, impacting 8,198 units nationwide. This event underscores critical supply chain vulnerabilities and the imperative for robust quality control in pharmaceutical distribution. Procurement and regulatory teams must reassess supplier qualification and stability testing protocols to mitigate similar future disruptions.