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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 36 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0396-2024 | fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230 | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0405-2024 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016 | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0401-2024 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164 | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0410-2024 | HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321 | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0416-2024 | PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0414-2024 | PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012 | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0400-2024 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964 | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0417-2024 | PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022. | SCA Pharmaceuticals, LLC | Terminated | Class II | Apr 3, 2024 |
| D-0391-2024 | Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11 | Eugia US LLC | Ongoing | Class II | Mar 27, 2024 |
| D-0393-2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001. | Super Chill Products | Terminated | Class I | Mar 27, 2024 |
| D-0390-2024 | Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10 | Eugia US LLC | Ongoing | Class II | Mar 27, 2024 |
| D-0392-2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01 | Hikma Pharmaceuticals USA Inc. | Ongoing | Class II | Mar 27, 2024 |
| D-0389-2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20 | Novitium Pharma LLC | Terminated | Class III | Mar 27, 2024 |
| D-0388-2024 | Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30. | Micro Labs Limited | Terminated | Class II | Mar 20, 2024 |
| D-0385-2024 | Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01. | Eugia US LLC | Completed | Class II | Mar 20, 2024 |
| D-0374-2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 | Thea Pharma, Inc. | Terminated | Class II | Mar 20, 2024 |
| D-0387-2024 | Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12 | Global Corporation | Ongoing | Class II | Mar 20, 2024 |
| D-0377-2024 | TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15. | Optikem International, Inc. | Ongoing | Class II | Mar 20, 2024 |
| D-0372-2024 | Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01 | Mckesson Medical-Surgical Inc. Corporate Office | Terminated | Class II | Mar 20, 2024 |
| D-0371-2024 | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10 | Mckesson Medical-Surgical Inc. Corporate Office | Terminated | Class II | Mar 20, 2024 |
| D-0378-2024 | TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15. | Optikem International, Inc. | Ongoing | Class II | Mar 20, 2024 |
| D-0380-2024 | TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15. | Optikem International, Inc. | Ongoing | Class II | Mar 20, 2024 |
| D-0381-2024 | TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15. | Optikem International, Inc. | Ongoing | Class II | Mar 20, 2024 |
| D-0379-2024 | TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15. | Optikem International, Inc. | Ongoing | Class II | Mar 20, 2024 |
| D-0373-2024 | Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10 | Mckesson Medical-Surgical Inc. Corporate Office | Terminated | Class II | Mar 20, 2024 |