FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 164 of 348
Moderate Feb 20, 2019
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy, LLC
Moderate Feb 20, 2019
CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 10…
LGM Pharma LLC
Moderate Feb 13, 2019
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle,…
Mylan Pharmaceuticals Inc.
Critical Feb 13, 2019
the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry…
Natures Rx
Moderate Feb 13, 2019
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL …
US Pharmaceuticals Inc.
Moderate Feb 13, 2019
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-…
US Pharmaceuticals Inc.
Moderate Feb 13, 2019
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 03…
US Pharmaceuticals Inc.
Low Feb 13, 2019
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lup…
Lupin Pharmaceuticals Inc.
Moderate Feb 6, 2019
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheija…
Prinston Pharmaceutical Inc
Moderate Feb 6, 2019
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
H J Harkins Company Inc dba Pharma Pac
Moderate Feb 6, 2019
Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 005…
Duren Health Mart Pharmacy
Moderate Feb 6, 2019
Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0…
Duren Health Mart Pharmacy
Moderate Feb 6, 2019
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin …
Lupin Pharmaceuticals Inc.
Moderate Feb 6, 2019
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured b…
Mylan Pharmaceuticals Inc.
Moderate Feb 6, 2019
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distr…
Prinston Pharmaceutical Inc
Moderate Feb 6, 2019
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC …
Sun Pharmaceutical Industries, Inc.
Moderate Feb 6, 2019
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheija…
Prinston Pharmaceutical Inc
Moderate Feb 6, 2019
Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98
Duren Health Mart Pharmacy
Moderate Feb 6, 2019
Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, …
Duren Health Mart Pharmacy
Moderate Feb 6, 2019
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Lin…
Prinston Pharmaceutical Inc
Moderate Feb 6, 2019
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Akorn, Inc.
Moderate Feb 6, 2019
Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002…
Duren Health Mart Pharmacy
Moderate Feb 6, 2019
Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai,…
Prinston Pharmaceutical Inc
Moderate Feb 6, 2019
Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485…
Duren Health Mart Pharmacy
Moderate Jan 30, 2019
Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epin…
Bound Tree Medical, LLC
Moderate Jan 30, 2019
Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partn…
Bound Tree Medical, LLC
Moderate Jan 30, 2019
curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-…
Bound Tree Medical, LLC
Moderate Jan 30, 2019
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dres…
Bound Tree Medical, LLC
Low Jan 30, 2019
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories…
Sun Pharmaceutical Industries, Inc.
Critical Jan 30, 2019
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Happy Together, Inc.
Moderate Jan 30, 2019
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manu…
LUPIN SOMERSET
Moderate Jan 30, 2019
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avell…
Advanced Pharma Inc.
Moderate Jan 30, 2019
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Isra…
Dr. Reddy's Laboratories, Inc.
Moderate Jan 23, 2019
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-76…
Teva Pharmaceuticals USA
Moderate Jan 23, 2019
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit …
Bound Tree Medical, LLC
Moderate Jan 23, 2019
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, I…
Syntho Pharmaceuticals, Inc.
Moderate Jan 23, 2019
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 658…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., …
Syntho Pharmaceuticals, Inc.
Moderate Jan 23, 2019
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810.…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 6586…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 658…
Aurobindo Pharma USA Inc.
Low Jan 23, 2019
Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 In…
Bound Tree Medical, LLC
Moderate Jan 23, 2019
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 658…
Aurobindo Pharma USA Inc.
Moderate Jan 23, 2019
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manu…
Lupin Pharmaceuticals Inc.
Moderate Jan 16, 2019
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pha…
Lupin Pharmaceuticals Inc.