Total records
16,790
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
Sorted by most recent report date.
Recall # | Product | Firm | Status | Classification | Report date |
---|---|---|---|---|---|
D-1663-2012 | Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15 | Bracco Diagnostics Inc | Terminated | Class III | Sep 5, 2012 |
D-1653-2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3. | Noven Pharmaceuticals, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1654-2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5555-3. | Noven Pharmaceuticals, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1655-2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. | Noven Pharmaceuticals, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1652-2012 | Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01. | Victus, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1649-2012 | Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description. | Custom Medical Specialties, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1650-2012 | CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description. | Custom Medical Specialties, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1656-2012 | Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743. | Morton Salt Co. | Terminated | Class III | Aug 29, 2012 |
D-1658-2012 | Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50 | VistaPharm, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1651-2012 | CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description. | Custom Medical Specialties, Inc. | Terminated | Class II | Aug 29, 2012 |
D-1659-2012 | Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. | Prometheus Laboratories Inc. | Terminated | Class II | Aug 29, 2012 |
D-1657-2012 | V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746 | The Menz Club, LLC | Terminated | Class I | Aug 29, 2012 |
D-1648-2012 | Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia | Hospira Inc. | Terminated | Class III | Aug 22, 2012 |
D-1524-2012 | FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1631-2012 | TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1604-2012 | POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1510-2012 | DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1623-2012 | TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1493-2012 | CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1548-2012 | IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (10 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1470-2012 | BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML, 250 ML, 300 ML, 500 ML, 60 ML; BUPIVACAINE HCL 0.5% INJECTABLE1000 ML, 120 ML, 200 ML, 250 ML, 400 ML, 50 ML, 500 ML, 600 ML, 750 ML; BUPIVACAINE HCL, P.F. 0.25% INJECTABLE 1000 ML, 120 ML, 1200 ML, 150 ML, 1500 ML, 180 ML, 240 ML, 300 ML, 60 ML, 600 ML, 900 ML; BUPIVACAINE HCL, P.F. 0.5% INJECTABLE 10 ML, 120 ML, 1500 ML, 20 ML, 200 ML, 240 ML, 2500 ML, 300 ML, 360 ML, 600 ML, 960 ML; BUPIVACAINE HCL, P.F. 0.75% INJECTABLE 1200 ML, 150 ML, 240 ML, 30 ML, 600 ML, 7 ML (47 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1487-2012 | COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1523-2012 | FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1461-2012 | BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |
D-1579-2012 | MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Terminated | Class II | Aug 22, 2012 |