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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 1081–1100 of 18,048 recalls

ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5

Church & Dwight Inc

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

June 6, 2025 · DrugView details →

ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6

Church & Dwight Inc

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

June 6, 2025 · DrugView details →

Class IIOngoing

KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →

Class IIOngoing

LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →

Class IIOngoing

KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →

Class IIOngoing

BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →

Class IIOngoing

LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Amneal Pharmaceuticals, LLC

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

June 2, 2025 · DrugView details →

Class IIOngoing

LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →

Class IICompleted

Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.

Zydus Pharmaceuticals (USA) Inc

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

May 30, 2025 · DrugView details →

Class IIOngoing

TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01

Advanced Pharmaceutical Technology, Inc.

Marketed Without an Approved NDA/ANDA

May 30, 2025 · DrugView details →

Class IIOngoing

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25

Eugia US LLC

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

May 29, 2025 · DrugView details →

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 IICompleted

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 →

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