Drug Enforcements

Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.

Total records

16,790

Most recent report

September 24, 2025

Last updated

September 30, 2025

Drug Enforcement Records

Sorted by most recent report date.

Back to datasets Page 627 of 672
Recall # Product Firm Status Classification Report date
D-821-2013 AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30. Gilead Sciences, Inc. Terminated Class II Jul 31, 2013
D-820-2013 AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30. Astellas Pharma US Inc Terminated Class II Jul 31, 2013
D-813-2013 Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20. Hospira Inc. Terminated Class II Jul 31, 2013
D-809-2013 Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA. Mobius Therapeutics LLC Terminated Class I Jul 31, 2013
D-808-2013 Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 Pharmalucence, Inc. Terminated Class III Jul 31, 2013
D-816-2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM Max Huber Research Labs, Inc. Terminated Class III Jul 31, 2013
D-823-2013 Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880. Watson Laboratories Inc Terminated Class III Jul 31, 2013
D-814-2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM Max Huber Research Labs, Inc. Terminated Class III Jul 31, 2013
D-812-2013 ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5. Vi-Jon, Inc. Terminated Class III Jul 31, 2013
D-815-2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM Max Huber Research Labs, Inc. Terminated Class III Jul 31, 2013
D-825-2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724 West-ward Pharmaceutical Corp. Terminated Class II Jul 31, 2013
D-811-2013 All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712 Med Prep Consulting, Inc. Terminated Class II Jul 31, 2013
D-818-2013 Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071 Oklahoma Respiratory Care Inc Terminated Class II Jul 31, 2013
D-824-2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724 West-ward Pharmaceutical Corp. Terminated Class II Jul 31, 2013
D-810-2013 Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712 Med Prep Consulting, Inc. Terminated Class I Jul 31, 2013
D-819-2013 VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451, Alkermes, Inc. Terminated Class II Jul 31, 2013
D-803-2013 Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960. Teva Pharmaceuticals USA, Inc. Terminated Class III Jul 24, 2013
D-801-2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511. Church & Dwight Inc Terminated Class II Jul 24, 2013
D-806-2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0. Apotex Corp. Terminated Class I Jul 24, 2013
D-800-2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411. Church & Dwight Inc Terminated Class II Jul 24, 2013
D-799-2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60311. Church & Dwight Inc Terminated Class II Jul 24, 2013
D-797-2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111. Church & Dwight Inc Terminated Class II Jul 24, 2013
D-804-2013 Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. Fresenius Kabi USA, LLC Terminated Class II Jul 24, 2013
D-807-2013 Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin Bayer Healthcare Pharmaceuticals Inc. Terminated Class III Jul 24, 2013
D-805-2013 Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 Sandoz Incorporated Terminated Class II Jul 24, 2013