FDA (Drugs) recall action 93820
The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Sun Pharmaceutical recalls 6,552 bottles of Niacin Extended-Release Tablets (1000mg) nationwide due to microbial contamination in manufacturing equipment. No illnesses have been reported.
Sun Pharmaceutical recalls 9,408 bottles of Lurasidone Hydrochloride 120mg tablets nationwide due to microbial contamination discovered in manufacturing equipment.
Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.
Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.
Sun Pharmaceutical recalls 55,272 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination detected in manufacturing equipment. No illnesses have been reported.
Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.
Sun Pharmaceutical is recalling 11,400 bottles of Lurasidone Hydrochloride 60mg tablets due to microbial contamination in manufacturing equipment. Patients taking this medication should contact their doctor or pharmacist.
Sun Pharmaceutical recalls 10,690 bottles of Mesalamine tablets nationwide due to microbial contamination found in manufacturing equipment. Patients should contact their healthcare provider.
SUN PHARMACEUTICAL INDUSTRIES is recalling 14,568 bottles of Zolpidem Tartrate Extended-Release 12.5mg tablets nationwide due to microbial contamination discovered in manufacturing equipment. Affected lot: DNE0893A (expires 07/31/2026).
Sun Pharmaceutical is recalling Febuxostat 80 mg tablets due to microbial contamination in manufacturing equipment. Approximately 19,992 bottles were distributed nationwide.
Sun Pharmaceutical is recalling approximately 1220 bottles of Zolpidem Tartrate Extended-Release 6.25 mg tablets distributed nationwide due to microbial contamination detected in manufacturing equipment.