Recalls and safety alerts from the FDA, newest first.
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
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
Turkana Food Inc. Kenilworth, NJ is recalling 858 cases OF Aleppo Tahini Sesame Paste because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system