FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Dissolution Specifications
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 27, 20262026 recordClass II
SHEANDRO LLC
- Product
- Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 1…
- Reason
- Label declares cream and cheese, but Milk is not declared
- Published
- August 19, 2026
- Distribution
- Product distributed in Florida
View recall →
FDA Recall
Ongoing2026 recordClass II
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass I
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
by Sunny Pharmtech Inc.
- Reason
- Presence of Particulate Matter; identified as stainless steel
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass I
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
by Sunny Pharmtech Inc.
- Reason
- Presence of Particulate Matter; identified as stainless steel
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
by Aurobindo Pharma USA Inc
- Reason
- shortfill; reports of empty capsules.
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
AKKARCO LLC
- Product
- Ashfiat Alharamain Energy Support 250ml/8fl. oz.
- Reason
- Undeclared tadalafil
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass III
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass III
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass III
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.
by MYLAN PHARMACEUTICALS INC
- Reason
- Presence of precipitate
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
- Published
- August 5, 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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