FDA Enforcement Records
Explore FDA enforcement records
Browse published US FDA drug-enforcement recall records. Filter by country, classification, status, or date.
Showing 1251–1275 of 5,012 active FDA enforcement records
- View firm →Class IIOngoingDuloxetine 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 · Mar 19, 2025 · United States
- View firm →Class IIOngoingDuloxetine Delayed-Release Capsules, USP, 60mg, 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 51991-748-10 · Mar 19, 2025 · United States
- View firm →Class IOngoingPOTASSIUM 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 · Mar 19, 2025 · United States
- View firm →Class IOngoingPOTASSIUM 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 · Mar 19, 2025 · United States
- View firm →Class IIOngoingUnisom, 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 · Mar 19, 2025 · United States
- View firm →Class IIOngoingVoriconazole 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. · Mar 19, 2025 · India
- View firm →Class IIOngoingLatanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle · Mar 19, 2025 · India
- View firm →Class IIOngoingChlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. · Mar 19, 2025 · India
- View firm →Class IIOngoingFinasteride 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. · Mar 19, 2025 · India
- View firm →Class IIOngoingAlprostadil Container Description: Amber color bottle · Mar 19, 2025 · India
- View firm →Class IIOngoingBimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. · Mar 19, 2025 · India
- View firm →Class IOngoingBD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31. · Mar 19, 2025 · United States
- View firm →Class IIICompletedLivalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case · Mar 19, 2025 · United States
- View firm →Class IITerminatedSodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50 · Mar 19, 2025 · United States
- View firm →Class IIOngoingNelarabine 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 · Mar 12, 2025 · United States
- View firm →Class IIOngoingNelarabine 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 · Mar 12, 2025 · United States
- View firm →Class IIOngoingMorphine 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. · Mar 12, 2025 · United States
- View firm →Class IIOngoingLorazepam 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. · Mar 12, 2025 · United States
- View firm →Class IIOngoingFerrous 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. · Mar 12, 2025 · United States
- View firm →Class IIOngoingSimethicone 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. · Mar 12, 2025 · United States
- View firm →Class IIOngoingErgocalciferol - 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. · Mar 12, 2025 · United States
- View firm →Class IIOngoingMorphine 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 · Mar 12, 2025 · United States
- View firm →Class IICompletedAvastin 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. · Mar 5, 2025 · United States
- View firm →Class IIOngoingViaMed 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. · Mar 5, 2025 · China
- View firm →Class IICompletedEstradiol 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 · Mar 5, 2025 · United States
Only the latest five years of published US FDA drug-enforcement recall records are indexed. The displayed entity is an FDA-recorded recalling firm; country, city, and state are source attributes, not proof of manufacturer, parent company, ownership, legal entity, safety, compliance, or approval.