Major Pharmaceuticals recalled 26,628 cartons of Carvedilol Tablets on August 20, 2025. The recall stems from N-Nitroso Carvedilol Impurity-1 levels exceeding FDA limits. Consumers should stop using the product immediately and consult their healthcare provider.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter
The recalled product is Carvedilol Tablets USP, 12.5 mg, packaged in 100-tablet cartons. The affected lot number is T05693, with an expiration date of March 2026. The product was distributed nationwide across the United States.
Testing revealed N-Nitroso Carvedilol Impurity-1 levels above the FDA-recommended limit of 4.0 ppm. This impurity can pose health risks if consumed in excess.
No specific incidents or injuries have been reported in connection with this recall. However, the impurity levels have raised significant health concerns.
Consumers should stop using Carvedilol Tablets immediately. Contact Major Pharmaceuticals or your healthcare provider for guidance on the next steps.
For more information, contact The Harvard Drug Group LLC at [contact number not provided]. Visit the FDA website for further details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0594-2025.
Glenmark Pharmaceuticals Inc. recalled 13,824 tubes of Azelaic Acid Gel on September 17, 2025. The recall stems from market complaints regarding a gritty texture. Consumers should stop using the product immediately and contact their healthcare provider.
Skin MD by Dr Monika Kiripolsky recalled its Body Acne Cleanser on September 12, 2025. The recall follows the discovery of elevated benzene levels in the product. This contamination poses a high health risk to consumers in California and Georgia.
Private Label Skin Care recalled its Micronized BPO Gel Cleanser 10% on September 12, 2025. Elevated benzene levels prompted the recall in California and Georgia. Consumers must stop using the product immediately and seek guidance from healthcare providers.