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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
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01 Syntho Pharmaceuticals, Inc. Class II Terminated 20190123
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01 Syntho Pharmaceuticals, Inc. Class II Terminated 20190123
curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Producs, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016 Bound Tree Medical, LLC Class II Terminated 20190123
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. Class II Ongoing 20190123
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30. Aurobindo Pharma USA Inc. Class II Ongoing 20190123
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30 Aurobindo Pharma USA Inc. Class II Ongoing 20190123
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07 Allergan, PLC. Class II Completed 20190116
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA Lupin Pharmaceuticals Inc. Class II Terminated 20190116
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 Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA Lupin Pharmaceuticals Inc. Class II Terminated 20190116
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478. PharMEDium Services, LLC. Class II Terminated 20190116
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton] Sun Pharmaceutical Industries, Inc. Class I Terminated 20190116
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton] Sun Pharmaceutical Industries, Inc. Class I Terminated 20190116
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10. Lupin Pharmaceuticals Inc. Class I Terminated 20190116
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. Lupin Pharmaceuticals Inc. Class I Terminated 20190116
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. Lupin Pharmaceuticals Inc. Class I Terminated 20190116
Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. Lupin Pharmaceuticals Inc. Class I Terminated 20190116
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31 Heritage Pharmaceuticals, Inc. Class II Terminated 20190116
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52. Baxter Healthcare Corporation Class II Terminated 20190116
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ Glenmark Pharmaceuticals Inc., USA Class II Terminated 20190116
Lidocaine gel 1%, RX, plastic dropper Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Glutathione liquid, 200mg/ml, Rx Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Cyclosporin liquid 0.05%, Rx, plastic dropper bottle Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Cyclosporin liquid 0.2%, Rx, plastic dropper bottle Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Cyclosporin liquid 0.5%, Rx, plastic dropper bottle Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Cyclosporin liquid 1%, Rx, plastic dropper bottle Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Vitamin B12 liquid 1000mcg/ml, RX, glass vial Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Testosteron Cypionate liquid 200mg/ml, RX, glass vial Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Methocarbamol liquid 100mg/ml, RX, glass vial Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Lidocaine gel 2%, RX, plastic dropper Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
HCG liquid, 1000u/ml, RX, glass vial, various Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Glutathione liquid, 100mg/ml Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Epinephrine liquid 1:1000, RX, glass vial Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Class II Terminated 20190109
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11. LUPIN SOMERSET Class II Terminated 20190109
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61. Advanced Pharma Inc. Class I Terminated 20190102
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14 Amerigen Pharmaceuticals Inc. Class III Terminated 20190102
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ Amerigen Pharmaceuticals Inc. Class III Terminated 20190102
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack) Sun Pharmaceutical Industries, Inc. Class III Terminated 20181226
Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02 Cipla Limited Class II Terminated 20181226
Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4 Results RNA, LLC Class I Terminated 20181226