Drug Recalls

1,948 drug recalls from federal enforcement feeds.

Showing 1–50 of 1,948

• Drug Recall · August 5, 2026

  Zydus Pharmaceuticals (USA) Inc

  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,

  CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

  Class II

• Drug Recall · August 4, 2026

  Novartis Pharmaceuticals Corporation

  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 007

  Failed Dissolution Specifications

  Class II

• Drug Recall · August 3, 2026

  Shoolin Pharma Chem LLP

  SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-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, Mah

  CGMP Deviations:Noted during FDA inspection

  Class II

• Drug Recall · August 3, 2026

  Shoolin Pharma Chem LLP

  TADALAFIL USP, 1.00 KG, 1KG(1000gm)-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, Gu

  CGMP Deviations:Noted during FDA inspection

  Class II

• Drug Recall · August 3, 2026

  Shoolin Pharma Chem LLP

  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, Mah

  CGMP Deviations:Noted during FDA inspection

  Class II

• Drug Recall · August 3, 2026

  Shoolin Pharma Chem LLP

  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,

  CGMP Deviations:Noted during FDA inspection

  Class II

• Drug Recall · August 3, 2026

  Shoolin Pharma Chem LLP

  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

  CGMP Deviations:Noted during FDA inspection

  Class II

• Drug Recall · July 31, 2026

  Liebel-Flarsheim Company LLC

  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, Ralei

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

  Class I

• Drug Recall · July 30, 2026

  Heritage Pharmaceuticals Inc

  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.

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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 71170-721-0

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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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 71170-711-0

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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Prestige Brands Holdings

  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

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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 29, 2026

  Apollo Care, LLC

  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

  Class II

• Drug Recall · July 23, 2026

  Aurobindo Pharma USA Inc

  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 59651-719-9

  shortfill; reports of empty capsules.

  Class II

• Drug Recall · July 23, 2026

  Glenmark Pharmaceuticals Inc., USA

  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.

  CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

  Class II

• Drug Recall · July 22, 2026

  MICRO LABS USA INC

  Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. ND

  Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

  Class II

• Drug Recall · July 17, 2026

  Sunny Pharmtech Inc.

  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

  Presence of Particulate Matter; identified as stainless steel

  Class I

• Drug Recall · July 17, 2026

  Sunny Pharmtech Inc.

  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

  Presence of Particulate Matter; identified as stainless steel

  Class I

• Drug Recall · July 16, 2026

  Ascend Laboratories, LLC

  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

  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

  Class III

• Drug Recall · July 16, 2026

  Fresenius Kabi USA, LLC

  Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial:

  Presence of Particulate Matter: Hair was found in products

  Class II

• Drug Recall · July 16, 2026

  Ascend Laboratories, LLC

  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 PHARMACEUTICAL

  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

  Class III

• Drug Recall · July 16, 2026

  Fresenius Kabi USA, LLC

  Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 6

  Presence of Particulate Matter: Hair was found in product

  Class II

• Drug Recall · July 16, 2026

  Fresenius Kabi USA, LLC

  Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial:

  Presence of Particulate Matter: Hair was found in products

  Class II

• Drug Recall · July 16, 2026

  Ascend Laboratories, LLC

  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,

  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

  Class III

• Drug Recall · July 16, 2026

  Central Admixture Pharmacy Services Inc

  Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharm

  Incorrect Product Formulation

  Class III

• Drug Recall · July 16, 2026

  Fresenius Kabi USA, LLC

  Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; N

  Presence of Particulate Matter: Hair was found in products

  Class II

• Drug Recall · July 16, 2026

  Fresenius Kabi USA, LLC

  Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323

  Presence of Particulate Matter: Hair was found in products

  Class II

• Drug Recall · July 15, 2026

  Asclemed USA Inc.

  Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.

  Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

  Class III

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, U

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 14, 2026

  Precision Dose Inc.

  Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

  Failed Impurities/Degradation Specifications

  Class II

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Mad

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in V

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietn

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127,

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 14, 2026

  Rohto-Mentholatum (Vietnam) Co., Ltd.

  Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made

  Lack of Assurance of Sterility

  Class II

• Drug Recall · July 13, 2026

  Major Pharmaceuticals

  Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. N

  Subpotent Drug

  Class II

• Drug Recall · July 13, 2026

  Rising Pharma Holding, Inc.

  Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton

  Presence of Precipitate: medication was crystallizing and particles floating in the bottle

  Class II

• Drug Recall · July 13, 2026

  Major Pharmaceuticals

  Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Dist

  Subpotent Drug

  Class II

• Drug Recall · July 13, 2026

  Major Pharmaceuticals

  Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC

  Subpotent Drug

  Class II

• Drug Recall · July 13, 2026

  Major Pharmaceuticals

  Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. N

  Subpotent Drug

  Class II