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Lisdexamfetamine 10mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Sodium Chloride Injection (Otsuka) - Sterility Risk (2025)

Lack of Assurance of Sterility: Potential for flexible container leaks.

Class IIModerate

FDAOct 27, 2025Nationwide• Otsuka ICU Medical LLC

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Lisdexamfetamine 10mg Capsules (Sun) - Dissolution Failure (2025)

Sodium Chloride Injection (Otsuka) - Sterility Risk (2025)

Lanthanum Carbonate Tablets (Cipla) - Stability Failure (2025)

My Bladder Supplement (Water Pure) – E. coli Contamination (2025)

Deli Express BBQ Pulled Pork (E.A. Sween) – Foreign Material Hazard (2025)

Lanthanum Carbonate Tablets (Cipla) - Stability Failure (2025)

Ice Cream Factory Graham Pieces – Foreign Material Risk (2025)

Bromocriptine Capsules (Zydus) - Impurity Deviation (2025)

Clomipramine 25mg Capsules (Zydus) - Nitrosamine Risk (2025)

Clomipramine 50mg Capsules (Zydus) - Nitrosamine Risk (2025)

Clomipramine 75mg Capsules (Zydus) - Nitrosamine Risk (2025)

Opdualag Injection (Bristol-Myers Squibb) – Sterility Concern (2025)

TYLENOL Extra Strength Acetaminophen (Kenvue) – Defective Container (2025)

NIACIN Extended-Release Tablets (Golden State) – Dissolution Failure (2025)

Sea Salt Caramel Cheddar Popcorn (Jody's Inc.) - Undeclared Peanuts (2025)

Cinnamon Powder (Haitai, Inc.) - Elevated Lead Levels (2025)

Acetaminophen Caffeine Caplets (Aero) – Labeling Mix-up (2025)

Prazosin Hydrochloride 5mg Capsules (Amerisource) – Impurity Risk (2025)

Prazosin Hydrochloride 1mg Capsules (Amerisource) – Impurity Risk (2025)

Cinnamon Whiskey Pecans (Nats Nuts) - Undeclared Cashews (2025)