FDA Recall
Ongoing2026 recordClass I
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
by Baxter Healthcare Corporation
- Reason
- Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
- Published
- September 16, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass III
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
by Ajanta Pharma USA Inc
- Reason
- Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
- Published
- September 16, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass III
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
by ImprimisRx NJ LLC
- Reason
- Subpotent Drug
- Published
- September 16, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing2026 recordClass II
L-Nutra Inc
- Product
- Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47…
- Reason
- Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
- Published
- September 16, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass I
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
by OPTIMAL BALANCE PHARMACY
- Reason
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Published
- September 9, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
by Golden State Medical Supply Inc.
- Reason
- Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
- Published
- September 9, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass III
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
by American Health Packaging
- Reason
- Labeling: Label Mix-up
- Published
- September 9, 2026
- Distribution
- Nationwide
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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
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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
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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
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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
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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
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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
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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
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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 →
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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