FDA Recall
Ongoing
Historical recordClass II
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.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vita Warehouse Corp.
- Product
- 1. Welby Vitamin B12 Adult Gummies 140 Count 2. Berkely Jens…
- Reason
- Contains undeclared peanut
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Peak Cocktails
- Product
- Peak Cocktails Blood Orange Spritz 8.4 fl oz aluminum cans s…
- Reason
- Overpressurization leading to exploding cans
- Published
- July 9, 2025
- Distribution
- Product was distributed to consumers in:…
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% 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.
by B BRAUN MEDICAL INC
- Reason
- Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Pfizer Inc.
- Reason
- Discoloration; discolored solution from cracked vials
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tirzepatide/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
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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