Sun Pharmaceutical recalls 120mg Lurasidone Hydrochloride tablets due to microbial contamination in manufacturing equipment. Affected lots expire 11/30/2024 and 12/31/2024. Consumers should contact the manufacturer for details.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical is recalling 120mg Lurasidone Hydrochloride tablets that may have microbial contamination from manufacturing equipment. This could pose a health risk if the tablets are taken without proper cleaning.
Microbial contamination was found in stagnant water within the manufacturing equipment's duct system. This could lead to harmful bacteria entering the tablets during production, potentially causing health issues if consumed.
Prescription patients who received the recalled lot numbers DNE0621A (expiring 11/30/2024) or DNE0815A (expiring 12/31/2024) are affected. Patients using these specific lot numbers should contact the manufacturer.
Check the product label for the lot numbers DNE0621A or DNE0815A. The tablets are 120mg, prescription-only, and come in 30-tablet bottles with NDC 47335-579-83.
Look for lot numbers DNE0621A or DNE0815A on the tablet packaging.
Sun Pharmaceutical is recalling 120mg Lurasidone Hydrochloride tablets that may have microbial contamination from manufacturing equipment.
Check the product label for lot numbers DNE0621A (expiring 11/30/2024) or DNE0815A (expiring 12/31/2024).
Contact Sun Pharmaceutical directly for instructions on what to do with the product.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0267-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0267-2024 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.