Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0573-2021 | 03-15-2021 | Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 26895 inhalers | Class II | Terminated |
| D-0559-2021 | 03-15-2021 | Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distributed by Nature's Truth LLC. Ronkonkoma, NY 11779, UPC 840093100672 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 8 bottles | Class II | Terminated |
| D-0514-2021 | 03-15-2021 | VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 380 BOTTLE | Class II | Terminated |
| D-0478-2021 | 03-15-2021 | ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 297 inhalers | Class II | Terminated |
| D-0519-2021 | 03-15-2021 | VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 427 BOTTLE | Class II | Terminated |
| D-0546-2021 | 03-15-2021 | Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 321 bottles | Class II | Terminated |
| D-0409-2021 | 03-15-2021 | LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 240 bottles | Class II | Terminated |
| D-0596-2021 | 03-15-2021 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 15 bottles | Class II | Terminated |
| D-0462-2021 | 03-15-2021 | Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 16 tubes | Class II | Terminated |
| D-0505-2021 | 03-15-2021 | SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 78 bottles | Class II | Terminated |
| D-0597-2021 | 03-15-2021 | Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 10 bottles | Class II | Terminated |
| D-0444-2021 | 03-15-2021 | BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2 carton | Class II | Terminated |
| D-0410-2021 | 03-15-2021 | Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 424 bottles | Class II | Terminated |
| D-0580-2021 | 03-15-2021 | Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Package NDCs: 0591-2927-54 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 828 inhalers | Class II | Terminated |
| D-0400-2021 | 03-15-2021 | THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 55 bottles | Class II | Terminated |
| D-0574-2021 | 03-15-2021 | NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01 Package NDCs: 0093-1177-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 41 bottles | Class II | Terminated |
| D-0487-2021 | 03-15-2021 | Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 23 tubes | Class II | Terminated |
| D-0541-2021 | 03-15-2021 | RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 39 bottles | Class II | Terminated |
| D-0521-2021 | 03-15-2021 | PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 147 | Class II | Terminated |
| D-0557-2021 | 03-15-2021 | LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 13 bottles | Class II | Terminated |
| D-0447-2021 | 03-15-2021 | DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 318 droptainers | Class II | Terminated |
| D-0522-2021 | 03-15-2021 | Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 119 cartons | Class II | Terminated |
| D-0563-2021 | 03-15-2021 | medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 148 syringes | Class II | Terminated |
| D-0467-2021 | 03-15-2021 | Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1 bottle | Class II | Terminated |
| D-0465-2021 | 03-15-2021 | CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 40 bags | Class II | Terminated |
| D-0578-2021 | 03-15-2021 | EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27 Package NDCs: 0093-5986-19; 0093-5986-27; 0093-5985-19; 0093-5985-27 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1776 boxes | Class II | Terminated |
| D-0415-2021 | 03-15-2021 | UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 964 bottles | Class II | Terminated |
| D-0454-2021 | 03-15-2021 | ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 667 inhalers | Class II | Terminated |
| D-0530-2021 | 03-15-2021 | NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 47 bottles | Class II | Terminated |
| D-0589-2021 | 03-15-2021 | VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 796 bottles | Class II | Terminated |
| D-0531-2021 | 03-15-2021 | Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 523 bottles | Class II | Terminated |
| D-0588-2021 | 03-15-2021 | INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 32 bottles | Class II | Terminated |
| D-0471-2021 | 03-15-2021 | Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 504 cartons | Class II | Terminated |
| D-0438-2021 | 03-15-2021 | Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520 Package NDCs: 59651-104-06; 59651-104-69; 59651-105-06; 59651-105-69; 59651-105-93 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 20 CARTONS | Class II | Terminated |
| D-0468-2021 | 03-15-2021 | BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 75 bottles | Class II | Terminated |
| D-0492-2021 | 03-15-2021 | LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 298 bottles | Class II | Terminated |
| D-0460-2021 | 03-15-2021 | PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 3 bottles | Class II | Terminated |
| D-0558-2021 | 03-15-2021 | PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 49 CARTON | Class II | Terminated |
| D-0477-2021 | 03-15-2021 | FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 237 inhalers | Class II | Terminated |
| D-0516-2021 | 03-15-2021 | VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 19 BOTTLE | Class II | Terminated |
| D-0440-2021 | 03-15-2021 | ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1935 bottles | Class II | Terminated |
| D-0549-2021 | 03-15-2021 | Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05. Package NDCs: 0574-0611-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 180 bottles | Class II | Terminated |
| D-0456-2021 | 03-15-2021 | Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 284 bottles | Class II | Terminated |
| D-0479-2021 | 03-15-2021 | ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 513 inhalers | Class II | Terminated |
| D-0406-2021 | 03-15-2021 | METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 51 bottles | Class II | Terminated |
| D-0405-2021 | 03-15-2021 | Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 123 bottles | Class II | Terminated |
| D-0515-2021 | 03-15-2021 | VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 53 BOTTLE | Class II | Terminated |
| D-0585-2021 | 03-15-2021 | Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 80 bottles | Class II | Terminated |
| D-0594-2021 | 03-15-2021 | Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2 bottles | Class II | Terminated |
| D-0446-2021 | 03-15-2021 | TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 47 droptainers | Class II | Terminated |
| D-0540-2021 | 03-15-2021 | HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 236 bottles | Class II | Terminated |
| D-0416-2021 | 03-15-2021 | RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 3688 bottles | Class II | Terminated |
| D-0569-2021 | 03-15-2021 | COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 133 bottles | Class II | Terminated |
| D-0498-2021 | 03-15-2021 | INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 534 syringes | Class II | Terminated |
| D-0503-2021 | 03-15-2021 | Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 422 bottles | Class II | Terminated |
| D-0493-2021 | 03-15-2021 | LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 12 bottles | Class II | Terminated |
| D-0443-2021 | 03-15-2021 | LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 463 boxes | Class II | Terminated |
| D-0504-2021 | 03-15-2021 | Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 357 bottles | Class II | Terminated |
| D-0501-2021 | 03-15-2021 | PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 16 bottles | Class II | Terminated |
| D-0511-2021 | 03-15-2021 | MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 71 tubes | Class II | Terminated |
| D-0534-2021 | 03-15-2021 | Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 348 droptainers | Class II | Terminated |
| D-0537-2021 | 03-15-2021 | Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 60 bottles | Class II | Terminated |
| D-0502-2021 | 03-15-2021 | PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 237 bottles | Class II | Terminated |
| D-0567-2021 | 03-15-2021 | Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30 Package NDCs: 50484-010-30; 50484-010-90 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1391 tubes | Class II | Terminated |
| D-0565-2021 | 03-15-2021 | HYDROCORTISONE 1% 30gm cream | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 143 tubes | Class II | Terminated |
| D-0587-2021 | 03-15-2021 | Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 cartons | Class II | Terminated |
| D-0414-2021 | 03-15-2021 | Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 72 tubes | Class II | Terminated |
| D-0548-2021 | 03-15-2021 | Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1371 bottles | Class II | Terminated |
| D-0466-2021 | 03-15-2021 | Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland Package NDCs: 70515-625-01; 70515-610-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 13 packets | Class II | Terminated |
| D-0586-2021 | 03-15-2021 | TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 86 BOTTLE | Class II | Terminated |
| D-0525-2021 | 03-15-2021 | ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 122 inhalers | Class II | Terminated |
| D-0506-2021 | 03-15-2021 | Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA Package NDCs: 62175-617-46; 62175-617-43; 62175-180-46; 62175-180-43; 62175-618-46; 62175-618-43 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 4 bottles | Class II | Terminated |
| D-0494-2021 | 03-15-2021 | Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA Package NDCs: 0143-9722-01; 0143-9722-24; 0143-9721-01; 0143-9721-24; 0143-9720-01; 0143-9720-24 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 35 bags | Class II | Terminated |
| D-0420-2021 | 03-15-2021 | Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 759 bottles | Class II | Terminated |
| D-0577-2021 | 03-15-2021 | EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27 Package NDCs: 0093-5986-19; 0093-5986-27; 0093-5985-19; 0093-5985-27 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 414 boxes | Class II | Terminated |
| D-0536-2021 | 03-15-2021 | Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark Package NDCs: 0169-1715-30; 0169-1715-90; 0169-1704-30; 0169-1709-30; 0169-4303-01; 0169-4303-13; 0169-4303-90; 0169-4303-93; 0169-4303-30; 0169-4303-99; 0169-4307-01; 0169-4307-13; 0169-4307-30; 0169-4314-01; 0169-4314-13; 0169-4314-30; 0169-4815-30; 0169-4815-90; 0169-4804-30; 0169-4809-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1189 cartons | Class II | Terminated |
| D-0555-2021 | 03-15-2021 | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56 Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-28; 0069-0471-03; 0069-0471-28 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 848 bottles | Class II | Terminated |
| D-0432-2021 | 03-15-2021 | GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 3 CARTON | Class II | Terminated |
| D-0595-2021 | 03-15-2021 | CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL Package NDCs: 69680-112-01; 69680-112-25; 69680-112-10; 69680-113-10; 69680-113-99; 69680-121-05; 69680-121-30; 69680-121-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 6 boxes | Class II | Terminated |
| D-0448-2021 | 03-15-2021 | Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612. Package NDCs: 59385-021-01; 59385-021-60; 59385-022-01; 59385-022-60; 59385-023-01; 59385-023-60; 59385-024-01; 59385-024-60; 59385-025-01; 59385-025-60; 59385-026-01; 59385-026-60; 59385-027-01; 59385-027-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 96 cartons | Class II | Terminated |
| D-0318-2021 | 03-11-2021 | ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4. | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc / 1569 devices | Class II | Terminated |
| D-0317-2021 | 03-11-2021 | ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5. | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc / 301 devices | Class II | Terminated |
| D-0305-2021 | 03-11-2021 | Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01. Package NDCs: 25021-315-01; 25021-315-99; 25021-315-98 | Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product. | Sagent Pharmaceuticals Inc / 3716 cartons | Class II | Terminated |
| D-0308-2021 | 03-11-2021 | Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10 | Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. | Breckenridge Pharmaceutical, Inc / 3,146 bottles | Class II | Terminated |
| D-0365-2021 | 03-10-2021 | heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0. | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. | PNHC, LLC. / 139,806 bottles | Class I | Terminated |
| D-0790-2021 | 03-10-2021 | aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005, Package NDCs: 76305-302-03; 76305-302-02; 76305-302-01 | CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. | China Gel Inc / 3458 tubes | Class II | Ongoing |
| D-0788-2021 | 03-10-2021 | CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005, Package NDCs: 76305-300-02; 76305-300-03; 76305-300-04; 76305-300-05; 76305-300-06; 76305-300-07; 76305-300-13 | CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. | China Gel Inc / 92,472 each | Class II | Ongoing |
| D-0789-2021 | 03-10-2021 | CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005, Package NDCs: 76305-301-02; 76305-301-03; 76305-301-04; 76305-301-05; 76305-301-06; 76305-301-07; 76305-301-13 | CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. | China Gel Inc / 40,289 each | Class II | Ongoing |
| D-0659-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243. | CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated. | Sanit Technologies, LLC dba Durisan / 43,164 canisters TOTAL | Class II | Terminated |
| D-0657-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8. | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold. | Sanit Technologies, LLC dba Durisan / 42,905 canisters TOTAL | Class I | Terminated |
| D-0656-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243 | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold. | Sanit Technologies, LLC dba Durisan / 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL | Class I | Terminated |
| D-0658-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243 | CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated. | Sanit Technologies, LLC dba Durisan / 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL | Class II | Terminated |
| D-0314-2021 | 03-09-2021 | Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01. Package NDCs: 57894-650-01; 57894-650-02; 57894-640-01; 57894-640-04; 57894-640-11; 57894-640-99; 57894-640-03; 57894-640-06; 57894-651-01; 57894-651-02; 57894-651-04; 57894-651-11; 57894-651-22; 57894-651-99; 57894-651-92 | Temperature Abuse | Cardinal Health Inc. / 48 boxes | Class III | Terminated |
| D-0313-2021 | 03-09-2021 | 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09 Package NDCs: 0990-7138-09; 0990-7138-36; 0990-6138-22; 0990-6138-03; 0990-7972-05; 0990-7972-07 | Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use | ICU Medical Inc / 425,628 bottles | Class II | Terminated |
| D-0301-2021 | 03-08-2021 | Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07 | Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing | Akorn, Inc. / 8,183 unit dose cups | Class II | Terminated |
| D-0309-2021 | 03-04-2021 | Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01 | Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing. | Teva Pharmaceuticals USA / 1,416 vials | Class III | Terminated |
| D-0299-2021 | 03-02-2021 | Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc. Package NDCs: 55566-7501-1; 55566-7501-2; 55566-7502-0; 55566-1600-0; 55566-7501-3 | Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP | Ferring Pharmaceuticals Inc / 1,155,601 cartons/5 vials per carton 12546 physician samples | Class III | Terminated |
| D-0358-2021 | 03-02-2021 | Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves. Package NDCs: 50090-5350-0; 50090-5350-1 | Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label. | A-S Medication Solutions LLC. / 201,600 kits | Class I | Terminated |
| D-0300-2021 | 03-02-2021 | Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330 | cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site. | Direct Rx / 17 bottles | Class II | Terminated |
| D-0649-2021 | 02-26-2021 | Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03 Package NDCs: 47781-355-11; 47781-355-03; 47781-356-11; 47781-356-03; 47781-357-11; 47781-357-03; 47781-358-11; 47781-358-03 | Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) | Alvogen, Inc / 9,696 cartons | Class II | Terminated |
