The latest headlines across every section, pulled from official and open-access sources.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit — Cipla USA, Inc. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Labelling: Illegible label — Nephron SC, LLC · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Failed Dissolution Specifications — The Harvard Drug Group LLC · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Chemical contamination: Presence of benzene — Owen Biosciences Inc. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Lack of Assurance of Sterility — Huons Co., Ltd. · Class II · Ongoing
Subpotent Drug — Island Kinetics, Inc. d.b.a. CoValence Laboratories · Class III · Ongoing
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit — Cipla USA, Inc. · Class II · Ongoing
Lack of Assurance of Sterility — Huons Co., Ltd. · Class II · Ongoing
Subpotent drug — Avantor Performance Materials LLC · Class III · Ongoing
Lack of Assurance of Sterility — Huons Co., Ltd. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Chemical contamination: Presence of benzene — Owen Biosciences Inc. · Class II · Ongoing
Failed Stability Specifications — Island Kinetics, Inc. d.b.a. CoValence Laboratories · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing