Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed. — Premier Dental Products Co · Class III · Ongoing
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin — Teva Pharmaceuticals USA, Inc · Class II · Ongoing
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." — Hetero Labs Limited (Unit V) · 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
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
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
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