Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0755-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 250 vials. | Class II | Ongoing |
| D-0752-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 4,748 vials. | Class II | Ongoing |
| D-0753-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 250 vials. | Class II | Ongoing |
| D-0749-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 37,546 vials. | Class II | Ongoing |
| D-0754-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 250 vials. | Class II | Ongoing |
| D-0757-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 4,250 vials. | Class II | Ongoing |
| D-0747-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 56,918 vials. | Class II | Ongoing |
| D-0748-2026 | 07-29-2026 | 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 | Apollo Care, LLC / 23,029 vials. | Class II | Ongoing |
| D-0766-2026 | 07-29-2026 | 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 | Prestige Brands Holdings / 39,060 15mL-bottles | Class II | Ongoing |
| D-0764-2026 | 07-29-2026 | PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1 Package NDCs: 70121-2453-1; 70121-2461-1; 70121-2462-1 | Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials | Shilpa Medicare Limited / 18,434 10mL vials | Class II | Ongoing |
| D-0765-2026 | 07-29-2026 | PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1 Package NDCs: 70121-2453-1; 70121-2461-1; 70121-2462-1 | Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials | Shilpa Medicare Limited / 9,489 50mL vials | Class II | Ongoing |
| D-0767-2026 | 07-28-2026 | Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01 Package NDCs: 61755-008-01; 8494000002 | Lack of Assurance of Sterility | Regeneron Pharmaceuticals Inc / 21,353 vials | Class II | Ongoing |
| D-0801-2026 | 07-24-2026 | Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-9305-01; 0517-9305-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 323,000 vials | Class II | Ongoing |
| D-0796-2026 | 07-24-2026 | ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-7504-25; 0517-7604-25; 0517-7510-03; 0517-7610-03; 0517-7630-03; 0517-7504-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 316,450 vials | Class II | Ongoing |
| D-0795-2026 | 07-24-2026 | Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967. Package NDCs: 0517-1004-01; 0517-1004-25; 0517-1001-01; 0517-1001-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 89,775 vials | Class II | Ongoing |
| D-0794-2026 | 07-24-2026 | AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967. Package NDCs: 0517-9120-25; 0517-9120-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 63,200 vials | Class II | Ongoing |
| D-0792-2026 | 07-24-2026 | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-0031-01; 0517-0031-25; 0517-0032-01; 0517-0032-25; 0517-0130-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 235,350 vials | Class II | Ongoing |
| D-0798-2026 | 07-24-2026 | Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-6560-01; 0517-6560-05; 0517-6502-01; 0517-6502-10 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 41,680 vials | Class II | Ongoing |
| D-0793-2026 | 07-24-2026 | Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-0031-01; 0517-0031-25; 0517-0032-01; 0517-0032-25; 0517-0130-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 26,450 vials | Class II | Ongoing |
| D-0774-2026 | 07-24-2026 | Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80. Package NDCs: 0378-6333-80 | Failed Dissolution Specifications | Mylan Pharmaceuticals Inc / | Class II | Ongoing |
| D-0791-2026 | 07-24-2026 | Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967. Package NDCs: 0517-4810-01; 0517-4810-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 98,200 vials | Class II | Ongoing |
| D-0787-2026 | 07-24-2026 | 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 | Baxter Healthcare Corporation / 19,032 bags | Class I | Ongoing |
| D-0797-2026 | 07-24-2026 | ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-7504-25; 0517-7604-25; 0517-7510-03; 0517-7610-03; 0517-7630-03; 0517-7604-01 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 169,200 vials | Class II | Ongoing |
| D-0799-2026 | 07-24-2026 | Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-9302-01; 0517-9302-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 185,775 vials | Class II | Ongoing |
| D-0800-2026 | 07-24-2026 | Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Package NDCs: 0517-4002-01; 0517-4002-25 | Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde | American Regent, Inc. / 86,100 vials | Class I | Ongoing |
| D-0802-2026 | 07-24-2026 | niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054. Package NDCs: 72572-470-01; 72572-470-10 | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde | American Regent, Inc. / 43,460 vials | Class II | Ongoing |
| D-0731-2026 | 07-23-2026 | 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. Package NDCs: 68462-626-52 | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0733-2026 | 07-23-2026 | 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 Package NDCs: 59651-719-01; 59651-719-99 | shortfill; reports of empty capsules. | Aurobindo Pharma USA Inc / 6,408 bottles distributed to market | Class II | Ongoing |
| D-0730-2026 | 07-22-2026 | 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. NDC 42571-147-26. Package NDCs: 42571-147-26 | Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. | MICRO LABS USA INC / N/A | Class II | Ongoing |
| D-0743-2026 | 07-17-2026 | 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 | Sunny Pharmtech Inc. / 4,077 vials | Class I | Ongoing |
| D-0744-2026 | 07-17-2026 | 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 | Sunny Pharmtech Inc. / 1,464 vials | Class I | Ongoing |
| D-0740-2026 | 07-16-2026 | 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 Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418 | Incorrect Product Formulation | Central Admixture Pharmacy Services Inc / (2) patient-specific TPN prescriptions | Class III | Ongoing |
| D-0727-2026 | 07-16-2026 | 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; NDC Vial: 63323-286-05 Package NDCs: 63323-286-01; 63323-286-20; 63323-286-05; 63323-286-23; 63323-286-09; 63323-286-31; 63323-286-11; 63323-286-35; 63323-286-03; 63323-286-00; 63323-286-33; 63323-286-63; 63323-286-30; 63323-287-01; 63323-287-20; 63323-287-03; 63323-287-21; 63323-288-01; 63323-288-10; 63323-288-06; 63323-288-20; 63323-288-03; 63323-288-11; 63323-288-07; 63323-288-21; 63323-285-01; 63323-285-10; 63323-285-06; 63323-285-20; 63323-285-03; 63323-285-13; 63323-285-07; 63323-285-23; 63323-285-57; 63323-285-64; 63323-285-51; 63323-285-65; 63323-285-02; 63323-285-61; 63323-285-04; 63323-285-63 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 92,600 vials | Class II | Ongoing |
| D-0737-2026 | 07-16-2026 | 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. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | 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 | Ascend Laboratories, LLC / 3,600 cartons x 6 x 10 (in blister pack) | Class III | Ongoing |
| D-0728-2026 | 07-16-2026 | 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: 63323-485-01 Package NDCs: 63323-492-04; 63323-492-27; 63323-492-09; 63323-492-57; 63323-492-07; 63323-492-37; 63323-492-03; 63323-492-31; 63323-491-01; 63323-491-57; 63323-495-09; 63323-495-27; 63323-495-04; 63323-495-07; 63323-485-01; 63323-485-27; 63323-485-03; 63323-485-57; 63323-486-01; 63323-486-17; 63323-486-02; 63323-486-27; 63323-486-05; 63323-486-57; 63323-484-57; 63323-489-02; 63323-489-27; 63323-489-03; 63323-489-21; 63323-489-01; 63323-489-17; 63323-488-07; 63323-488-37; 63323-488-03; 63323-488-31; 63323-488-01; 63323-488-17; 63323-481-01; 63323-481-57; 63323-483-03; 63323-483-27; 63323-483-01; 63323-483-57; 63323-482-01; 63323-482-17; 63323-482-03; 63323-482-27; 63323-482-05; 63323-482-57; 63323-487-01; 63323-487-17; 63323-487-07; 63323-487-37; 63323-487-03; 63323-487-31 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 93,250 vials | Class II | Ongoing |
| D-0725-2026 | 07-16-2026 | 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: 63323-578-07 Package NDCs: 63323-578-03; 63323-578-01; 63323-578-04; 63323-578-02; 63323-578-07; 63323-578-05; 63323-578-18; 63323-578-20 | Presence of Particulate Matter: Hair was found in product | Fresenius Kabi USA, LLC / 59,425 vials | Class II | Ongoing |
| D-0726-2026 | 07-16-2026 | 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: 63323-208-01 Package NDCs: 63323-208-01; 63323-208-05 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 181,225 vials | Class II | Ongoing |
| D-0738-2026 | 07-16-2026 | 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. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | 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 | Ascend Laboratories, LLC / 924 cartons x 12 x 6 x 10 (in blister pack) | Class III | Ongoing |
| D-0739-2026 | 07-16-2026 | 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. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | 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 | Ascend Laboratories, LLC / 936 cartons x 12 x 3 x 10 (in blister pack) | Class III | Ongoing |
| D-0729-2026 | 07-16-2026 | 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: 63323-485-03 Package NDCs: 63323-492-04; 63323-492-27; 63323-492-09; 63323-492-57; 63323-492-07; 63323-492-37; 63323-492-03; 63323-492-31; 63323-491-01; 63323-491-57; 63323-495-09; 63323-495-27; 63323-495-04; 63323-495-07; 63323-485-01; 63323-485-27; 63323-485-03; 63323-485-57; 63323-486-01; 63323-486-17; 63323-486-02; 63323-486-27; 63323-486-05; 63323-486-57; 63323-484-57; 63323-489-02; 63323-489-27; 63323-489-03; 63323-489-21; 63323-489-01; 63323-489-17; 63323-488-07; 63323-488-37; 63323-488-03; 63323-488-31; 63323-488-01; 63323-488-17; 63323-481-01; 63323-481-57; 63323-483-03; 63323-483-27; 63323-483-01; 63323-483-57; 63323-482-01; 63323-482-17; 63323-482-03; 63323-482-27; 63323-482-05; 63323-482-57; 63323-487-01; 63323-487-17; 63323-487-07; 63323-487-37; 63323-487-03; 63323-487-31 | Presence of Particulate Matter: Hair was found in products | Fresenius Kabi USA, LLC / 37,250 vials | Class II | Ongoing |
| D-0713-2026 | 07-15-2026 | 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. Package NDCs: 76420-760-01; 55150-164-02; 70121-1049-5; 67777-419-02 | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Asclemed USA Inc. / 18 kits | Class III | Ongoing |
| D-0716-2026 | 07-14-2026 | 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 Vietnam, UPC 310742011012, NDC 10742-8158-1 Package NDCs: 10742-8158-1; 10742-8158-2; 3107420110 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 6076306 cartons | Class II | Ongoing |
| D-0720-2026 | 07-14-2026 | 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, NDC 10742-8162-1 Package NDCs: 10742-8162-1; 10742-8162-2; 3107420111 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 97201 cartons | Class II | Ongoing |
| D-0715-2026 | 07-14-2026 | 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 in Vietnam UPC 310742010862, NDC 10742-8146-1 Package NDCs: 10742-8146-1; 3107420108 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 1.033,266 cartons | Class II | Ongoing |
| D-0721-2026 | 07-14-2026 | 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, UPC 310742011159, NDC 10742-8162-2 Package NDCs: 10742-8162-1; 10742-8162-2; 3107420111 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 353 cartons | Class II | Ongoing |
| D-0741-2026 | 07-14-2026 | 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). Package NDCs: 68094-073-01; 68094-073-58 | Failed Impurities/Degradation Specifications | Precision Dose Inc. / N/A | Class II | Ongoing |
| D-0718-2026 | 07-14-2026 | 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, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1 Package NDCs: 10742-8160-1; 3107420109 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 1,278,457 cartons | Class II | Ongoing |
| D-0722-2026 | 07-14-2026 | 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 Vietnam, UPC 310742010749, NDC 10742-8141-1 Package NDCs: 10742-8141-1; 3107420107 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 2910148 cartons | Class II | Ongoing |
| D-0719-2026 | 07-14-2026 | 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 310742010602, NDC 10742-8175-1 Package NDCs: 10742-8175-1; 3107420106 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 65219 cartons | Class II | Ongoing |
| D-0717-2026 | 07-14-2026 | 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, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2 Package NDCs: 10742-8158-1; 10742-8158-2; 3107420112 | Lack of Assurance of Sterility | Rohto-Mentholatum (Vietnam) Co., Ltd. / 499,673 cartons | Class II | Ongoing |
| D-0724-2026 | 07-13-2026 | 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, MA. NDC 64980-504-48. Package NDCs: 64980-504-48 | Presence of Precipitate: medication was crystallizing and particles floating in the bottle | Rising Pharma Holding, Inc. / 74208 units | Class II | Ongoing |
| D-0708-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61; 55154-3559-0 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0706-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0701-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0702-2026 | 07-13-2026 | 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: 0904-6951-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0705-2026 | 07-13-2026 | 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. NDC: 0904-6955-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0700-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0703-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0709-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61; 55154-3560-0 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0707-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61; 55154-3558-0 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0711-2026 | 07-13-2026 | 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. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61; 55154-3563-0 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0704-2026 | 07-13-2026 | 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. NDC: 0904-6954-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0710-2026 | 07-13-2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61 Package NDCs: 0904-6949-61; 0904-6950-61; 0904-6951-61; 0904-6952-61; 0904-6953-61; 0904-6954-61; 0904-6955-61; 0904-6956-61; 0904-6957-61; 55154-3562-0 | Subpotent Drug | Major Pharmaceuticals / N/A | Class II | Ongoing |
| D-0690-2026 | 07-09-2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31 Package NDCs: 54365-400-31 | Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator | CareFusion 213, LLC / 43,066,599 units | Class II | Ongoing |
| D-0712-2026 | 07-08-2026 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30 Package NDCs: 67877-499-30; 67877-499-90; 67877-500-30; 67877-500-90; 67877-501-30; 67877-501-90; 67877-502-30; 67877-502-90 | Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications | Ascend Laboratories, LLC / 6,192 bottles | Class II | Ongoing |
| D-0758-2026 | 07-06-2026 | Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30. | Failed Dissolution Specifications | Supernus Pharmaceuticals, Inc. / 15,853 bottles | Class III | Ongoing |
| D-0689-2026 | 07-06-2026 | CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10. Package NDCs: 10122-611-01; 10122-611-10; 10122-610-01; 10122-610-10 | Lack of Assurance of Sterility | Chiesi USA, Inc. / 44280 vials | Class II | Ongoing |
| D-0734-2026 | 07-02-2026 | 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 (vial label) & NDC 67457-386-81 (carton label). Package NDCs: 67457-386-00; 67457-386-81 | Presence of precipitate | MYLAN PHARMACEUTICALS INC / 5688 vials | Class II | Ongoing |
| D-0772-2026 | 07-01-2026 | 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. | Victory Medical Center Pharmacy / 91 | Class I | Ongoing |
| D-0735-2026 | 06-30-2026 | Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. | Ascend Laboratories, LLC / 1,753 cartons | Class III | Ongoing |
| D-0736-2026 | 06-30-2026 | Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10. Package NDCs: 0904-7253-35; 0904-7253-04; 0904-7253-68; 0904-7254-35; 0904-7254-68; 0904-7255-35; 0904-7255-10; 0904-7255-68 | Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. | Ascend Laboratories, LLC / 2,717 cartons | Class III | Ongoing |
| D-0661-2026 | 06-29-2026 | Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Cipla USA, Inc. / 31,824 bottles | Class II | Ongoing |
| D-0676-2026 | 06-29-2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Cipla USA, Inc. / N/A | Class II | Ongoing |
| D-0675-2026 | 06-29-2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Cipla USA, Inc. / N/A | Class II | Ongoing |
| D-0742-2026 | 06-26-2026 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30. Package NDCs: 69452-433-13; 69452-433-20; 69452-433-30; 69452-434-13; 69452-434-20; 69452-434-30; 69452-435-13; 69452-435-20; 69452-435-30 | Presence of Foreign Tablets/Capsules | Bionpharma Inc. / N/A | Class II | Ongoing |
| D-0660-2026 | 06-26-2026 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37. Package NDCs: 0527-0790-37; 0527-0791-37; 0527-0792-37; 0527-0793-37; 0527-0794-37; 0527-0795-37 | Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. | Lannett Company Inc. / 1392 bottles | Class II | Ongoing |
| D-0685-2026 | 06-25-2026 | LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017. Package NDCs: 70000-0689-1; 70000-0688-1 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 5, 471 units | Class II | Ongoing |
| D-0684-2026 | 06-25-2026 | GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428. Package NDCs: 46122-556-05; 46122-557-05 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 20, 160 units | Class II | Ongoing |
| D-0681-2026 | 06-25-2026 | TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. Package NDCs: 36800-835-33; 36800-835-34 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 16,156 units | Class II | Ongoing |
| D-0687-2026 | 06-25-2026 | meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. Package NDCs: 41250-835-33 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 993 units | Class II | Ongoing |
| D-0688-2026 | 06-25-2026 | CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785. Package NDCs: 72476-838-34 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 1,201 units | Class II | Ongoing |
| D-0678-2026 | 06-25-2026 | CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895, Package NDCs: 51316-822-00; 51316-823-00 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 106,301 units | Class II | Ongoing |
| D-0682-2026 | 06-25-2026 | AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005. Package NDCs: 59256-001-02; 59256-836-34 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 5,762 units | Class II | Ongoing |
| D-0683-2026 | 06-25-2026 | FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320. Package NDCs: 55319-835-01; 55319-836-01 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 11, 977 units | Class II | Ongoing |
| D-0686-2026 | 06-25-2026 | Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141. | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 31,094 units | Class II | Ongoing |
| D-0679-2026 | 06-25-2026 | Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01. Package NDCs: 68229-102-01; 68229-102-03; 68229-102-02 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 29, 474 units | Class II | Ongoing |
| D-0680-2026 | 06-25-2026 | QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376. Package NDCs: 63868-026-15; 63868-027-16 | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Bell Pharmaceuticals, Inc / 15, 843 units | Class II | Ongoing |
| D-0732-2026 | 06-24-2026 | Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10. Package NDCs: 16571-401-10 | Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. | JB Chemicals and Pharmaceuticals Ltd / 34,020 100-count bottles. | Class I | Ongoing |
| D-0671-2026 | 06-24-2026 | Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01 | Lack of Sterility Assurance | Reliance Life Sciences Private Limited / 12,000 vials | Class II | Ongoing |
| D-0664-2026 | 06-24-2026 | Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46. | Failed Impurities/Degradation Specifications | QuVa Pharma, Inc. / N/A | Class II | Ongoing |
| D-0673-2026 | 06-24-2026 | Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01 | Lack of Sterility Assurance | Reliance Life Sciences Private Limited / 11,400 vials | Class II | Ongoing |
| D-0672-2026 | 06-24-2026 | Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01 | Lack of Sterility Assurance | Reliance Life Sciences Private Limited / 5,020 vials | Class II | Ongoing |
| D-0674-2026 | 06-24-2026 | Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01 | Lack of Sterility Assurance | Reliance Life Sciences Private Limited / 8,001 vials | Class II | Ongoing |
| D-0677-2026 | 06-23-2026 | Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35 Package NDCs: 45802-059-35; 45802-059-11 | Subpotent Drug: Low out of specification assay results performed during long-term stability testing. | Padagis US LLC / 180,936 tubes | Class II | Ongoing |
| D-0723-2026 | 06-23-2026 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01 Package NDCs: 70748-311-01; 70748-309-01; 70748-310-01 | CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. | Lupin Pharmaceuticals Inc. / 64,894 units | Class II | Ongoing |
| D-0617-2026 | 06-22-2026 | DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx. | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Direct Rx / 263 Bottles | Class II | Ongoing |
| D-0628-2026 | 06-17-2026 | Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6 Package NDCs: 51672-4205-6; 51672-4205-2; 51672-4204-6; 51672-4204-3; 51672-4206-6; 51672-4206-2; 51672-4207-6; 51672-4207-2; 51672-4208-6; 51672-4208-2; 51672-4209-6; 51672-4209-2 | Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. | SUN PHARMACEUTICAL INDUSTRIES INC / 3,456 30-count bottles | Class II | Ongoing |
| D-0609-2026 | 06-16-2026 | Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10. Package NDCs: 0904-7282-10 | Subpotent Drug | The Harvard Drug Group LLC / 790 Cartons. | Class II | Ongoing |
| D-0657-2026 | 06-12-2026 | Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45 | CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product. | Boehringer Ingelheim Pharmaceuticals, Inc. / 560 bottles | Class II | Ongoing |
| D-0596-2026 | 06-12-2026 | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05 Package NDCs: 42023-179-05 | Crystallization; identified as Buprenorphine free base | Par Health USA, LLC / 46,334 units | Class II | Ongoing |
