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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 801–820 of 1,000 recalls

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.

ACCORD HEALTHCARE, INC.

Subpotent

April 10, 2025 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17

ACCORD HEALTHCARE, INC.

Subpotent

April 10, 2025 · DrugView details →

Class IIOngoing

Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318

Apipharma

CGMP Deviations

April 9, 2025 · DrugView details →

Class IIOngoing

Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.

Cardinal Health Inc.

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

April 9, 2025 · DrugView details →

Class IIOngoing

Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363

Apipharma

CGMP Deviations

April 9, 2025 · DrugView details →

Class IIOngoing

chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1

Zydus Pharmaceuticals (USA) Inc

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

April 3, 2025 · DrugView details →

Class IIOngoing

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.

Amerisource Health Services LLC

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

April 2, 2025 · DrugView details →

Class IIOngoing

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.

Amerisource Health Services LLC

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

April 2, 2025 · DrugView details →

Class IIOngoing

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.

Amerisource Health Services LLC

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

April 2, 2025 · DrugView details →

Class IIOngoing

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11

Denver Solutions, LLC DBA Leiters Health

Lack of Assurance of Sterility: Leaking/damaged syringes.

March 31, 2025 · DrugView details →

Class IIOngoing

dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.

Denver Solutions, LLC DBA Leiters Health

Lack of Assurance of Sterility: Leaking/damaged syringes.

March 31, 2025 · DrugView details →

Class IIOngoing

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

B. Braun Medical Inc

Presence of Particulate Matter

March 31, 2025 · DrugView details →

Class IIOngoing

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11

Denver Solutions, LLC DBA Leiters Health

Lack of Assurance of Sterility: Leaking/damaged syringes.

March 31, 2025 · DrugView details →

Class IIOngoing

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

Denver Solutions, LLC DBA Leiters Health

Lack of Assurance of Sterility: Leaking/damaged syringes.

March 31, 2025 · DrugView details →

Class IIOngoing

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,

Denver Solutions, LLC DBA Leiters Health

Lack of Assurance of Sterility: Leaking/damaged syringes.

March 31, 2025 · DrugView details →

Class IIOngoing

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

Chattem Inc

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

March 26, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

Breckenridge Pharmaceutical, Inc.

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

March 26, 2025 · DrugView details →

Class IIOngoing

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

RemedyRepack Inc.

CGMP Deviations

March 24, 2025 · DrugView details →

Class IIOngoing

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

Somerset Therapeutics Private Limited

Lack of Assurance of Sterility: Media fill with bacterial contamination

March 21, 2025 · DrugView details →

Class IIOngoing

Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)

Somerset Therapeutics Private Limited

Lack of Assurance of Sterility: Media fill with bacterial contamination

March 21, 2025 · DrugView details →

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