Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2025-07-09FDA-DrugThe Harvard Drug Group LLCClass IIGabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
Defective container; blister packaging inadequately sealed.
- 2025-07-09FDA-DrugThe Harvard Drug Group LLCClass IIGabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
Defective container; blister packaging inadequately sealed.
- 2025-07-09FDA-DrugChurch & Dwight IncClass IOrajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
- 2025-07-09FDA-DrugChurch & Dwight IncClass IZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
- 2025-07-09FDA-DrugChurch & Dwight IncClass IZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
- 2025-07-09FDA-DrugTailstorm Health INCClass IILIDOcaine 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.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- 2025-07-09FDA-DrugTailstorm Health INCClass IILIDOcaine 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.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- 2025-07-09FDA-DrugTailstorm Health INCClass IIKETAmine 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.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- 2025-07-09FDA-DrugTailstorm Health INCClass IIKETAmine 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.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- 2025-07-09FDA-DrugTailstorm Health INCClass IIBUPIVAcaine 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.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- 2025-07-09FDA-DrugTailstorm Health INCClass IILIDOcaine 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.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- 2025-07-02FDA-DrugAdvanced Pharmaceutical Technology, Inc.Class IITESTO-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
Marketed Without an Approved NDA/ANDA
- 2025-07-02FDA-DrugApotex Corp.Class IIBrimonidine 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
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugApotex Corp.Class IIAzelastine 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
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugApotex Corp.Class IIKetorolac 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
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugB BRAUN MEDICAL INCClass II0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- 2025-07-02FDA-DrugFresenius Medical Care Holdings, Inc.Class II0.9% 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
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugPfizer Inc.Class IIDOBUTamine 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
Discoloration; discolored solution from cracked vials
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IINicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IITirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IITirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IITirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IITirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IITirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IISemaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IISemaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IISemaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IINicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IILX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
- 2025-07-02FDA-DrugThrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)Class IILL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lack of Assurance of Sterility
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief