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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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 |
| N/A | 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 | Due to an out-of-specification result for an unidentified impurity detected during routine stability testing. | Precision Dose Inc. / N/A | Not Yet Classified | 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: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 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-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-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-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-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: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 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: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 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-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: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 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-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-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: 55154-3558-0; 55154-3559-0; 55154-3560-0; 55154-4309-0; 55154-3561-0; 55154-3562-0; 55154-3563-0; 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-0652-2026 | 06-11-2026 | BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS. Package NDCs: 54365-400-34 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 100 units | Class II | Ongoing |
| D-0649-2026 | 06-11-2026 | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-36 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 1,200 units | Class II | Ongoing |
| D-0651-2026 | 06-11-2026 | BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB Package NDCs: 54365-400-31 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 18,000 units | Class II | Ongoing |
| D-0650-2026 | 06-11-2026 | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-39 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 125 units | Class II | Ongoing |
| D-0645-2026 | 06-11-2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-32 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 146,600 units | Class II | Ongoing |
| D-0644-2026 | 06-11-2026 | BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42. Package NDCs: 54365-014-42; 54365-014-41 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / N/A | Class II | Ongoing |
| D-0643-2026 | 06-11-2026 | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-35 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 1,800 units | Class II | Ongoing |
| D-0663-2026 | 06-11-2026 | Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04 Package NDCs: 53329-159-13; 53329-159-04; 53329-159-77; 53329-159-96; 0001882643; 0001887165; 0001888441; 0001900835; 0001931329; 0001951664; 0001882644; 0001899186; 0001903516; 0001905970; 0001911902; 0001917707; 0001920638; 0001927080; 0001937896; 0001952194; 0001962232; 0001981964; 0001981965; 0001994680; 0001998027 | Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. | BioMed Laboratories, LLC. / 509,652 tubes | Class II | Ongoing |
| D-0646-2026 | 06-11-2026 | ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB Package NDCs: 54365-400-30 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 10,500 units | Class II | Ongoing |
| D-0647-2026 | 06-11-2026 | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-33 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 7,650 units | Class II | Ongoing |
| D-0648-2026 | 06-11-2026 | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-38 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 400 units | Class II | Ongoing |
| D-0653-2026 | 06-10-2026 | IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26. Package NDCs: 69448-018-63; 69448-017-63; 69448-019-26 | Lack of assurance of Sterility: | ACCORD BIOPHARMA INC / 326 vials | Class II | Ongoing |
| D-0714-2026 | 06-10-2026 | Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01 Package NDCs: 0143-9340-01; 0143-9341-01; 0143-9342-01 | Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. | McKesson / 74 units | Class II | Ongoing |
| D-0656-2026 | 06-08-2026 | Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug | ACCORD HEALTHCARE, INC. / 6432 bottles | Class II | Ongoing |
| D-0658-2026 | 06-08-2026 | Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01. Package NDCs: 76420-715-01 | Lack of Assurance of Sterility | Asclemed USA Inc. / N/A | Class II | Ongoing |
| D-0659-2026 | 06-08-2026 | Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. Package NDCs: 85766-187-01; 85766-187-25 | Lack of Assurance of Sterility | Asclemed USA Inc. / N/A | Class II | Ongoing |
| D-0662-2026 | 06-07-2026 | Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31 Package NDCs: 23155-893-31 | Failed Impurities/Degradation Specifications | ONESOURCE SPECIALTY PHARMA LIMITED / 4284 vials | Class II | Ongoing |
| D-0610-2026 | 06-05-2026 | Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10 Package NDCs: 64980-599-01; 64980-599-10; 64980-600-01 | Failed Dissolution Specifications | Inventia Healthcare Limited / 11,460 bottles | Class II | Ongoing |
| D-0627-2026 | 06-04-2026 | Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. Package NDCs: 57511-0611-1 | sub potency | Elevate Oral Care / 8132 6-packs & 2262 2-packs | Class II | Ongoing |
| D-0655-2026 | 06-04-2026 | prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA Package NDCs: 70748-332-03; 70748-332-02; 70748-332-04 | Presence of Foreign Substance | Lupin Pharmaceuticals Inc. / 2,530,182 bottles | Class II | Ongoing |
| D-0613-2026 | 06-04-2026 | Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 Package NDCs: 55513-073-30; 55513-074-30; 55513-075-30 | CGMP Deviations | Amgen, Inc. / 9565 bottles | Class II | Ongoing |
| D-0616-2026 | 06-04-2026 | Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 Package NDCs: 55513-073-30; 55513-074-30; 55513-075-30 | CGMP Deviations | Amgen, Inc. / N/A | Class II | Ongoing |
| D-0626-2026 | 06-04-2026 | Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60. Package NDCs: 31722-812-60; 31722-812-18; 31722-812-05; 31722-812-32; 31722-813-60; 31722-813-18; 31722-813-05; 31722-813-32; 31722-814-60; 31722-814-18; 31722-814-05; 31722-814-32; 31722-815-60; 31722-815-18; 31722-815-05; 31722-815-32 | Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. | Annora Pharma Private Limited / 31,392 60-count bottles | Class II | Ongoing |
| D-0614-2026 | 06-04-2026 | Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 Package NDCs: 55513-073-30; 55513-074-30; 55513-075-30 | CGMP Deviations | Amgen, Inc. / N/A | Class II | Ongoing |
| D-0612-2026 | 06-04-2026 | Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. Package NDCs: 55513-800-60; 55513-800-99; 55513-810-60; 55513-813-01; 55513-813-28 | Presence of Foreign Substance. | Amgen, Inc. / 934577 bottles | Class II | Ongoing |
| D-0615-2026 | 06-04-2026 | Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60 Package NDCs: 55513-800-60; 55513-800-99; 55513-810-60; 55513-813-01; 55513-813-28 | Presence of Foreign Substance. | Amgen, Inc. / N/A | Class II | Ongoing |
| D-0595-2026 | 06-04-2026 | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. | Haleon US Holdings LLC / 35,883 boxes/carton | Class I | Ongoing |
| D-0583-2026 | 06-04-2026 | Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc. / 359,676 bottles | Class II | Ongoing |
| D-0582-2026 | 06-04-2026 | Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc. / 14,729 bottles. | Class II | Ongoing |
| D-0585-2026 | 06-03-2026 | Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 Package NDCs: 53746-544-01; 53746-544-10; 53746-544-05; 53746-545-01; 53746-545-10; 53746-545-05 | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. | Amneal Pharmaceuticals, LLC / 27,936 100-count bottles | Class III | Ongoing |
| D-0634-2026 | 06-02-2026 | Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 84 tubes | Class II | Ongoing |
| D-0631-2026 | 06-02-2026 | Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 2420 tubes | Class II | Ongoing |
| D-0641-2026 | 06-02-2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 3006 tubes | Class II | Ongoing |
| D-0640-2026 | 06-02-2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 4,944 tubes | Class II | Ongoing |
| D-0639-2026 | 06-02-2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 4,738 tubes | Class II | Ongoing |
| D-0619-2026 | 06-02-2026 | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 Package NDCs: 70954-912-10 | Presence of foreign substance | ANI Pharmaceuticals, Inc. / 6564 bottles | Class III | Ongoing |
| D-0638-2026 | 06-02-2026 | Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 5755 tubes | Class II | Ongoing |
| D-0642-2026 | 06-02-2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 8996 tubes | Class II | Ongoing |
| D-0636-2026 | 06-02-2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 4374 tubes | Class II | Ongoing |
| D-0635-2026 | 06-02-2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 1087 tubes | Class II | Ongoing |
| D-0633-2026 | 06-02-2026 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 84 tubes | Class II | Ongoing |
| D-0618-2026 | 06-02-2026 | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767. | Incorrect product formulation: bag did not contain copper and famotidine per label. | Central Admixture Pharmacy Services, Inc. / One (1) patient-specific TPN prescription. | Class II | Ongoing |
