FDA Drug Recalls

Class IIOngoing

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

Zydus Pharmaceuticals (USA) Inc

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

October 22, 2025 · DrugView details →

Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.

Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027

Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.

Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.

Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.

Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0

Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.

Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11

NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01

Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11