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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 721–740 of 1,000 recalls

Class IIIOngoing

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.

Macleods Pharmaceuticals Ltd

Presence of a foreign substance: black hair found embedded in tablet.

May 29, 2025 · DrugView details →

Class IIOngoing

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2

Apotex Corp.

Lack of Assurance of Sterility

May 28, 2025 · DrugView details →

Class IIOngoing

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4

Apotex Corp.

Lack of Assurance of Sterility

May 28, 2025 · DrugView details →

Class IIOngoing

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62

Pfizer Inc.

Discoloration; discolored solution from cracked vials

May 28, 2025 · DrugView details →

Class IIOngoing

Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4

Apotex Corp.

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

May 28, 2025 · DrugView details →

Class IIOngoing

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3

Apotex Corp.

Lack of Assurance of Sterility

May 28, 2025 · DrugView details →

Class IIOngoing

Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)

Torrent Pharma Inc.

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

May 27, 2025 · DrugView details →

Class IIOngoing

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility

May 27, 2025 · DrugView details →

Class IIOngoing

Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30

Torrent Pharma Inc.

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

May 27, 2025 · DrugView details →

Class IIOngoing

Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.

Teva Pharmaceuticals USA, Inc

Presence of foreign tablets/capsules.

May 23, 2025 · DrugView details →

Class IIOngoing

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68

Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

May 23, 2025 · DrugView details →

Class IIOngoing

Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5

Consumer Product Partners, LLC

Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol

May 23, 2025 · DrugView details →

Class IIOngoing

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88

Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

May 23, 2025 · DrugView details →

Class IIOngoing

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

Aurobindo Pharma USA Inc

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

May 22, 2025 · DrugView details →

Class IIOngoing

Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

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