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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 16 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0264-2025 | Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle | Aspen Biopharma Labs Pvt., Ltd. | Ongoing | Class II | Mar 19, 2025 |
| D-0274-2025 | Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8 | Sigan Industries Group Inc. | Ongoing | Class II | Mar 19, 2025 |
| D-0263-2025 | Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. | Aspen Biopharma Labs Pvt., Ltd. | Ongoing | Class II | Mar 19, 2025 |
| D-0261-2025 | Alprostadil Container Description: Amber color bottle | Aspen Biopharma Labs Pvt., Ltd. | Ongoing | Class II | Mar 19, 2025 |
| D-0265-2025 | Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. | Aspen Biopharma Labs Pvt., Ltd. | Ongoing | Class II | Mar 19, 2025 |
| D-0266-2025 | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0 | Chattem Inc | Ongoing | Class II | Mar 19, 2025 |
| D-0271-2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 | Breckenridge Pharmaceutical, Inc. | Ongoing | Class II | Mar 19, 2025 |
| D-0267-2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267 | ICU Medical, Inc. | Ongoing | Class I | Mar 19, 2025 |
| D-0262-2025 | Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. | Aspen Biopharma Labs Pvt., Ltd. | Ongoing | Class II | Mar 19, 2025 |
| D-0272-2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1. | Central Admixture Pharmacy Services, Inc. | Ongoing | Class I | Mar 19, 2025 |
| D-0270-2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 | Breckenridge Pharmaceutical, Inc. | Ongoing | Class II | Mar 19, 2025 |
| D-0268-2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 | ICU Medical, Inc. | Ongoing | Class I | Mar 19, 2025 |
| D-0255-2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ | Zydus Pharmaceuticals (USA) Inc | Ongoing | Class II | Mar 12, 2025 |
| D-0250-2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302. | Safecor Health, LLC | Ongoing | Class II | Mar 12, 2025 |
| D-0249-2025 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01 | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing | Class II | Mar 12, 2025 |
| D-0253-2025 | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784. | Safecor Health, LLC | Ongoing | Class II | Mar 12, 2025 |
| D-0251-2025 | Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375. | Safecor Health, LLC | Ongoing | Class II | Mar 12, 2025 |
| D-0254-2025 | Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750. | Safecor Health, LLC | Ongoing | Class II | Mar 12, 2025 |
| D-0252-2025 | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059. | Safecor Health, LLC | Ongoing | Class II | Mar 12, 2025 |
| D-0256-2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ | Zydus Pharmaceuticals (USA) Inc | Ongoing | Class II | Mar 12, 2025 |
| D-0246-2025 | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 | Padagis US LLC | Completed | Class II | Mar 5, 2025 |
| D-0248-2025 | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. | Turbare Manufacturing | Completed | Class II | Mar 5, 2025 |
| D-0247-2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01. | Wuxi Medical lnstrument Factory Co., Ltd. | Ongoing | Class II | Mar 5, 2025 |
| D-0228-2025 | Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Ongoing | Class II | Feb 26, 2025 |
| D-0242-2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Feb 26, 2025 |