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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 901–920 of 1,000 recalls

Class IIOngoing

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

Ascend Laboratories, LLC

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

July 9, 2025 · DrugView details →

Class IIOngoing

Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy

Boothwyn Pharmacy LLC

Subpotent Drug

July 9, 2025 · DrugView details →

Class IIOngoing

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

Strides Pharma, Inc.

Failed Dissolution Specifications.

July 9, 2025 · DrugView details →

Class IIOngoing

Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

Ascend Laboratories, LLC

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

July 9, 2025 · DrugView details →

Class IIOngoing

Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy

Boothwyn Pharmacy LLC

Subpotent Drug

July 9, 2025 · DrugView details →

Class IIOngoing

Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →

Class IIOngoing

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →

Class IIOngoing

ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →

Class IIOngoing

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →

Class IIOngoing

RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →

Class IIOngoing

H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →

Class IIOngoing

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

FDC Limited

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

July 5, 2025 · DrugView details →

Class IIOngoing

PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.

Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.

July 1, 2025 · DrugView details →

Class IIOngoing

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)

Cipla USA, Inc.

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

June 30, 2025 · DrugView details →

Class IIOngoing

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10

Dr. Reddy's Laboratories, Inc.

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

June 30, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

June 30, 2025 · DrugView details →

Class IIOngoing

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,

Granules Pharmaceuticals Inc.

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

June 24, 2025 · DrugView details →

Class IIOngoing

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01

Lupin Pharmaceuticals Inc.

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

June 20, 2025 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17

ACCORD HEALTHCARE, INC.

Subpotent Drug: Assay below the approved specification

June 20, 2025 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15

ACCORD HEALTHCARE, INC.

Subpotent Drug: Assay below the approved specification

June 20, 2025 · DrugView details →

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