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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
UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com. Med Man Distribution, Inc. Class I Terminated 20200325
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31 Par Pharmaceutical Inc. Class III Terminated 20200325
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50. Sun Pharmaceutical Industries, Inc. Class II Terminated 20200325
Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. Sun Pharmaceutical Industries, Inc. Class II Terminated 20200325
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01 Mylan Pharmaceuticals Inc. Class II Terminated 20200325
Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards). RemedyRepack Inc. Class II Terminated 20200325
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08 Strides Pharma Science Limited Class III Terminated 20200325
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-62 Perrigo Company PLC Class II Terminated 20200325
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51 Perrigo Company PLC Class II Terminated 20200325
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06 Perrigo Company PLC Class II Terminated 20200325
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47 Perrigo Company PLC Class II Terminated 20200325
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27 Perrigo Company PLC Class II Terminated 20200325
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12; Perrigo Company PLC Class II Terminated 20200325
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65 Perrigo Company PLC Class II Terminated 20200325
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. Lupin Pharmaceuticals Inc. Class II Terminated 20200318
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. Lupin Pharmaceuticals Inc. Class III Terminated 20200318
Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 Redline Pharmacy Solutions Class II Terminated 20200318
Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 Redline Pharmacy Solutions Class II Terminated 20200318
Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 Redline Pharmacy Solutions Class II Terminated 20200318
Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 Redline Pharmacy Solutions Class II Terminated 20200318
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 Redline Pharmacy Solutions Class II Terminated 20200318
Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 Redline Pharmacy Solutions Class II Terminated 20200318
Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433 H J Harkins Company Inc dba Pharma Pac Class II Terminated 20200318
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080 Precision Dose Inc. Class II Terminated 20200318
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11 American Health Packaging Class II Terminated 20200318
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61 The Harvard Drug Group Class III Terminated 20200318
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61 The Harvard Drug Group Class III Terminated 20200318
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61 The Harvard Drug Group Class III Terminated 20200318
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61 The Harvard Drug Group Class III Terminated 20200318
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01 Mayne Pharma Inc Class II Terminated 20200318
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01 Sunstar Guangzhou Ltd. Class II Terminated 20200318
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01 Pfizer Inc. Class II Terminated 20200311
Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Class II Terminated 20200311