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16,790
Drug Enforcements
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Most recent report
September 24, 2025
Last updated
September 30, 2025
Drug Enforcement Records
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Page 94 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0068-2023 | Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60 | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated | Class II | Nov 30, 2022 |
| D-0063-2023 | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 | Viatris Inc | Terminated | Class II | Nov 23, 2022 |
| D-0061-2023 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01 | Par Formulations Private Limited | Terminated | Class II | Nov 23, 2022 |
| D-0064-2023 | PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6. | Nephron Sterile Compounding Center LLC | Terminated | Class II | Nov 23, 2022 |
| D-0062-2023 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 | ICU Medical Inc | Ongoing | Class II | Nov 23, 2022 |
| D-0065-2023 | PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2. | Nephron Sterile Compounding Center LLC | Terminated | Class II | Nov 23, 2022 |
| D-0060-2023 | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ. | ImprimisRx NJ | Terminated | Class II | Nov 23, 2022 |
| D-0066-2023 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO. | Adam's Polishes LLC | Ongoing | Class I | Nov 23, 2022 |
| D-0067-2023 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO. | Adam's Polishes LLC | Ongoing | Class II | Nov 23, 2022 |
| D-0059-2023 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. | Aadi Bioscience | Terminated | Class III | Nov 23, 2022 |
| D-0058-2023 | Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton). | Viatris Inc | Terminated | Class I | Nov 16, 2022 |
| D-0025-2023 | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990. | Genentech Inc | Terminated | Class III | Nov 9, 2022 |
| D-0032-2023 | CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0056-2023 | VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0030-2023 | CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0029-2023 | BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0039-2023 | MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0054-2023 | SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0034-2023 | LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0055-2023 | TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0051-2023 | PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0050-2023 | PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0037-2023 | MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0047-2023 | PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |
| D-0035-2023 | LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing | Class II | Nov 9, 2022 |