FDA Recall
Ongoing2026 recordClass II
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
by MYLAN PHARMACEUTICALS INC
- Reason
- Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
by Sage Products, LLC
- Reason
- Cross Contamination with Other Products
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
by Teva Pharmaceuticals USA, Inc
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass III
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
by Supernus Pharmaceuticals, Inc.
- Reason
- Failed dissolution specifications.
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
by MYLAN PHARMACEUTICALS INC
- Reason
- Failed Dissolution Specifications
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
by Allies Group Inc.
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
by Allies Group Inc.
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
by Allies Group Inc.
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
by Allies Group Inc.
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass III
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
by Bionpharma Inc.
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations
- Published
- September 9, 2026
- 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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