Drugs & Medicine Recalls

Pharmaceutical recall notices, chemical impurities, and biological contamination.

Showing 24 of 610 results
PharmaceuticalUKUK

MHRA Safety Roundup: August 2026

MHRAUK
uk-mhraMedicines Recall

MHRA Safety Roundup: August 2026

Summary of the latest safety advice for medicines and medical device users...

Aug 25, 2026MHRA
PharmaceuticalAustraliaAustralia

CAROTONE skin-brightening products found to contain undeclared prescription-only medicine

TGAAustralia
au-tgaMedicines Safet...

CAROTONE skin-brightening products found to contain undeclared prescription-only medicine

We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used....

Aug 24, 2026TGA
PharmaceuticalUKUK

Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37

Zentiva Pharma UK LimitedUK
uk-mhraMedicines Recall

Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37

Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles....

Aug 20, 2026Zentiva Pharma UK Limited
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

Shoolin Pharma Chem LLP
FDA DrugsClass II

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

CGMP Deviations:Noted during FDA inspection

Aug 19, 2026Shoolin Pharma Chem LLP
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

Shoolin Pharma Chem LLP
FDA DrugsClass II

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

CGMP Deviations:Noted during FDA inspection

Aug 19, 2026Shoolin Pharma Chem LLP
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02

Apollo Care, LLC
FDA DrugsClass II

SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

Kian Pee Wan Capsules, 30-count bottles

Buy-Herbal
FDA DrugsClass I

Kian Pee Wan Capsules, 30-count bottles

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

Aug 19, 2026Buy-Herbal
PharmaceuticalUSFDA Drugs

SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/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 71170-721-01

Apollo Care, LLC
FDA DrugsClass II

SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/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 71170-721-01

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

Victory Medical Center Pharmacy
FDA DrugsClass I

Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Aug 19, 2026Victory Medical Center Pharmacy
PharmaceuticalUSFDA Drugs

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.

Shoolin Pharma Chem LLP
FDA DrugsClass II

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.

CGMP Deviations:Noted during FDA inspection

Aug 19, 2026Shoolin Pharma Chem LLP
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.

Liebel-Flarsheim Company LLC
FDA DrugsClass I

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Aug 19, 2026Liebel-Flarsheim Company LLC
PharmaceuticalUSFDA Drugs

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

Heritage Pharmaceuticals Inc
FDA DrugsClass II

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Aug 19, 2026Heritage Pharmaceuticals Inc
PharmaceuticalUSFDA Drugs

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3

Prestige Brands Holdings
FDA DrugsClass II

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3

Lack of assurance of sterility. The recall is due to potential contamination

Aug 19, 2026Prestige Brands Holdings
PharmaceuticalUSFDA Drugs

SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.

Apollo Care, LLC
FDA DrugsClass II

SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
PharmaceuticalUSFDA Drugs

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

Baxter Healthcare Corporation
FDA DrugsNot Yet Classified

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

Presence of Particulate Matter

Aug 19, 2026Baxter Healthcare Corporation
PharmaceuticalUSFDA Drugs

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

Novartis Pharmaceuticals Corporation
FDA DrugsClass 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

Failed Dissolution Specifications

Aug 19, 2026Novartis Pharmaceuticals Corporation
PharmaceuticalUSFDA Drugs

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

Apollo Care, LLC
FDA DrugsClass 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

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Aug 19, 2026Apollo Care, LLC
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