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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10 Macleods Pharma Usa Inc Class III Terminated 20200205
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11 Shandex Personal Care Manufacturing Inc. Class II Terminated 20200205
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704 McGuff Compounding Pharmacy Services, Inc. Class II Terminated 20200205
Testosterone Topical Cream 4% MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Tadalafil 6 mg Capsule MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Tadalafil 20 mg Troche MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
T3/T4 SR 9 mcg/38 mcg capsule MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Squaric Acid 0.1% Topical Solution (Clinic) 30 mL MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Sildenafil 80 mg capsules MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Sildenafil 200 mg Troche (Clinic) MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Progesterone E4M SR 100 mg capsules MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Progesterone 50 mg capsules MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Progesterone 200 mg Troche MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Naltrexone 4.5 mg capsule MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Magic Bullet Supplement MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Liothyronine (T3) 92.5 MCG MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Liothyronine (T3) 80 mcg SR cap MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
Finasteride/Biotin 1 mg/50 mcg MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
DHEA/Pregnenol One 10.25 MG Cap MPRX, Inc. dba Medical Park Pharmacy Class II Terminated 20200205
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01. Hikma Pharmaceuticals USA Inc. Class III Terminated 20200129
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302 Tuscano and Delucia Group (DBA Entropic Labs) Class II Terminated 20200129
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40. Advanced Accelerator Applications USA, Inc. Class II Terminated 20200129
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00 RemedyRepack Inc. Class II Terminated 20200129
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0) Preferred Pharmaceuticals, Inc Class II Terminated 20200129
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1) Preferred Pharmaceuticals, Inc Class II Terminated 20200129
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131 Denton Pharma, Inc. Class II Terminated 20200129
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131. Denton Pharma, Inc. Class II Terminated 20200129
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60 H J Harkins Company Inc dba Pharma Pac Class II Terminated 20200129
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93. Mylan Pharmaceuticals Inc. Class II Terminated 20200129
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91. Mylan Pharmaceuticals Inc. Class II Terminated 20200129
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA. Hikma Pharmaceuticals USA Inc. Class I Terminated 20200122
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704 McGuff Compounding Pharmacy Services, Inc. Class II Terminated 20200122
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet) Lupin Pharmaceuticals Inc. Class III Terminated 20200122
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03. AuroMedics Pharma LLC Class III Terminated 20200122
Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India Sun Pharmaceutical Industries, Inc. Class II Terminated 20200122
Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India Sun Pharmaceutical Industries, Inc. Class II Terminated 20200122
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. Sigan Industries Inc. Class III Terminated 20200122
Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062. Wisconsin Pharmacal Company, LLC Class II Terminated 20200122
Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601 Letco Medical LLC Class II Terminated 20200122
TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800 Assurance Infusion Class II Terminated 20200122