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-0673-2017 | 03-20-2017 | CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01 | Discoloration. | Valeant Pharmaceuticals North America LLC / 5,647 units | Class III | Terminated |
| D-0672-2017 | 03-20-2017 | CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04 | Discoloration. | Valeant Pharmaceuticals North America LLC / 38,767 units | Class III | Terminated |
| D-0619-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 299,112 bottles | Class II | Terminated |
| D-0621-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 452,269 bottles | Class II | Terminated |
| D-0620-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 444,201 bottles | Class II | Terminated |
| D-0618-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 1,233,107 bottles | Class II | Terminated |
| D-0636-2017 | 03-20-2017 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080. Package NDCs: 0713-0638-15; 0713-0638-31; 0713-0638-18 | Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. | G & W Laboratories, Inc. / 230,700 tubes | Class III | Terminated |
| D-0625-2017 | 03-17-2017 | Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 Package NDCs: 47783-101-01 | Presence of Particulate Matter: Glass | Shire / 3, 536 cartons (3 vials per carton) | Class II | Terminated |
| D-0790-2017 | 03-17-2017 | Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3 Package NDCs: 51672-1253-1; 51672-1253-2; 51672-1253-3; 51672-1253-4; 51672-1254-1; 51672-1254-2; 51672-1254-3; 51672-1279-1; 51672-1279-2; 51672-1279-3; 51672-1264-1; 51672-1264-2; 51672-1264-3 | Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate. | Taro Pharmaceuticals U.S.A., Inc. / 7,776 tubes | Class III | Terminated |
| D-0661-2017 | 03-17-2017 | LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12 | Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. | Akorn, Inc. / 107,940 bottles | Class II | Terminated |
| D-0647-2017 | 03-16-2017 | Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05 | Subpotent Drug | Fresenius Kabi USA, LLC / 118,224 vials | Class III | Terminated |
| D-0667-2017 | 03-16-2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08. Package NDCs: 0023-3205-02; 0023-3205-03; 0023-3205-05; 0023-3205-08 | Failed Impurities/Degradation Specifications | Allergan Sales, LLC / 56,878 bottles | Class III | Terminated |
| D-0611-2017 | 03-15-2017 | Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40 Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | Presence of Particulate Matter | Sun Pharmaceutical Industries, Inc. / 83,188 single does vials | Class II | Terminated |
| D-0617-2017 | 03-15-2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ | Failed Dissolution Specifications; 9 month long term stability | Zydus Pharmaceuticals USA Inc / 32628 bottles | Class II | Terminated |
| D-0648-2017 | 03-13-2017 | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01. Package NDCs: 50242-717-01 | Superpotent Drug: An oversized tablet was found in a bottle. | Genentech Inc. / 748 bottles | Class II | Terminated |
| D-0696-2017 | 03-13-2017 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16 | Failed Dissolution Specifications | Akorn Inc / 55,968 bottles | Class II | Terminated |
| D-0690-2017 | 03-12-2017 | EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company. Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication | Meridian Medical Technologies a Pfizer Company / 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.) | Class I | Ongoing |
| D-0691-2017 | 03-12-2017 | EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company. Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication | Meridian Medical Technologies a Pfizer Company / 92,544 2-pak (U.S.); 198,579 syringes (O.U.S.) | Class I | Ongoing |
| D-0613-2017 | 03-10-2017 | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 18,360 units (765 cartons x 24 bags) | Class II | Terminated |
| D-0615-2017 | 03-10-2017 | Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24 Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 24,456 units (1019 cartons x 24 bags) | Class II | Terminated |
| D-0616-2017 | 03-10-2017 | Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 72072 units | Class II | Terminated |
| D-0614-2017 | 03-10-2017 | Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 18,096 units (3016 cartons x 6 bags) | Class II | Terminated |
| D-0518-2017 | 03-08-2017 | Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1 | CGMP Deviations | Isomeric Pharmacy Solution, LLC / 6,999 single-use vials | Class II | Terminated |
| D-0668-2017 | 03-08-2017 | hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc. Package NDCs: 63323-614-00; 63323-614-01 | Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation. | Mckesson Medical Surgical / 98 vials | Class II | Terminated |
| D-0630-2017 | 03-07-2017 | Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01. | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0629-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0627-2017 | 03-07-2017 | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01. | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0633-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0634-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0631-2017 | 03-07-2017 | Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01. | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0632-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0635-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0628-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0563-2018 | 03-07-2017 | Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0557-2018 | 03-07-2017 | HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0570-2018 | 03-07-2017 | LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0556-2018 | 03-07-2017 | GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0565-2018 | 03-07-2017 | MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0560-2018 | 03-07-2017 | Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0552-2018 | 03-07-2017 | Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0569-2018 | 03-07-2017 | DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0567-2018 | 03-07-2017 | YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0562-2018 | 03-07-2017 | ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0564-2018 | 03-07-2017 | STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0607-2017 | 03-07-2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10). | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. | Pfizer Inc / 28,938 units | Class III | Terminated |
| D-0608-2017 | 03-07-2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25). | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. | Pfizer Inc / 11,862 units | Class III | Terminated |
| D-0555-2018 | 03-07-2017 | GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0609-2017 | 03-07-2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30). | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. | Pfizer Inc / 9,666 units | Class III | Terminated |
| D-0554-2018 | 03-07-2017 | Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0572-2018 | 03-07-2017 | Tiger King tablets, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0606-2017 | 03-07-2017 | ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54. | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. | Legacy Pharmaceutical Packaging LLC / 48,012 bottles | Class II | Terminated |
| D-0553-2018 | 03-07-2017 | Indian God Lotion Spray Bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class III | Terminated |
| D-0559-2018 | 03-07-2017 | GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0568-2018 | 03-07-2017 | Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0558-2018 | 03-07-2017 | LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0566-2018 | 03-07-2017 | HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0571-2018 | 03-07-2017 | MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0561-2018 | 03-07-2017 | Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0605-2017 | 03-06-2017 | ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. Package NDCs: 68382-022-16; 68382-022-01; 68382-022-10; 68382-022-40; 68382-022-24; 68382-023-16; 68382-023-01; 68382-023-10; 68382-023-02; 68382-023-40; 68382-023-24; 68382-024-16; 68382-024-01; 68382-024-10; 68382-024-40 | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. | Zydus Pharmaceuticals USA Inc / 9561 bottles | Class II | Terminated |
| D-0649-2017 | 03-06-2017 | RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60 Package NDCs: 55111-352-30; 55111-352-60; 55111-352-01; 55111-352-05; 55111-353-30; 55111-353-60; 55111-353-01; 55111-353-05; 55111-354-30; 55111-354-60; 55111-354-01; 55111-354-05; 55111-355-30; 55111-355-60; 55111-355-01; 55111-355-05 | Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine. | Dr. Reddy's Laboratories, Inc. / 1,728 bottles | Class III | Terminated |
| D-0624-2017 | 03-06-2017 | Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2 Package NDCs: 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01 | Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent | GSK Consumer Healthcare / 56,840 cases | Class II | Terminated |
| D-0612-2017 | 03-02-2017 | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60 | Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream | Fougera Pharmaceuticals Inc. / 14,665 tubes | Class II | Terminated |
| D-0662-2017 | 03-01-2017 | Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609. | Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination. | Signature Club A Ltd / 1,237 jars | Class II | Ongoing |
| D-0519-2017 | 02-28-2017 | Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092. | CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. | G & W Laboratories, Inc. / 39,816 bottles | Class III | Terminated |
| D-0652-2017 | 02-24-2017 | Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99 Package NDCs: 57237-040-01; 57237-040-99; 57237-041-01; 57237-041-05; 57237-041-99 | Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg | Citron Pharma Llc / 420 bottles | Class III | Terminated |
| D-0513-2017 | 02-23-2017 | Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01. | Presence of Foreign Substance: foreign material found in the bulk inventory. | Mckesson Packaging Services / 6,717 cartons | Class II | Completed |
| D-0512-2017 | 02-22-2017 | Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02. Package NDCs: 52244-010-02; 52244-010-06; 52244-020-02; 52244-020-06; 52244-040-02; 52244-040-06 | Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks | Endo Pharmaceuticals, Inc. / 5,086 cartridges | Class II | Terminated |
| D-0653-2017 | 02-22-2017 | Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60 Package NDCs: 43386-069-60 | Chemical Contamination | Novel Laboratories, Inc. / 7,656 bottles | Class III | Terminated |
| D-0829-2017 | 02-22-2017 | Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0835-2017 | 02-22-2017 | Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0823-2017 | 02-22-2017 | 0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0838-2017 | 02-22-2017 | Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0843-2017 | 02-22-2017 | Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0846-2017 | 02-22-2017 | Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0797-2017 | 02-22-2017 | Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0809-2017 | 02-22-2017 | Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0820-2017 | 02-22-2017 | Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0818-2017 | 02-22-2017 | Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0802-2017 | 02-22-2017 | NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0795-2017 | 02-22-2017 | Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0833-2017 | 02-22-2017 | Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0826-2017 | 02-22-2017 | Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0830-2017 | 02-22-2017 | Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0796-2017 | 02-22-2017 | Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0814-2017 | 02-22-2017 | Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0849-2017 | 02-22-2017 | Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0836-2017 | 02-22-2017 | Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0804-2017 | 02-22-2017 | Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0848-2017 | 02-22-2017 | Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0816-2017 | 02-22-2017 | Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0831-2017 | 02-22-2017 | Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0819-2017 | 02-22-2017 | Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0852-2017 | 02-22-2017 | Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0845-2017 | 02-22-2017 | Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0827-2017 | 02-22-2017 | Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0824-2017 | 02-22-2017 | Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0799-2017 | 02-22-2017 | NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0840-2017 | 02-22-2017 | Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0801-2017 | 02-22-2017 | Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0834-2017 | 02-22-2017 | Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
