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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
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50 Mayne Pharma Inc Class II Ongoing 20220126
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India. Dr. Reddy's Laboratories, Inc. Class III Terminated 20220126
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24. Lohxa, LLC Class I Terminated 20220126
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04 VistaPharm, Inc. Class II Terminated 20220126
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408. Ingenus Pharmaceuticals Llc Class II Terminated 20220126
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ Teva Pharmaceuticals USA Class II Terminated 20220126
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02. Akorn, Inc. Class II Terminated 20220119
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3 Taro Pharmaceuticals U.S.A., Inc. Class I Terminated 20220119
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02 Padagis US LLC Class II Terminated 20220119
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03. Teva Pharmaceuticals USA Class II Terminated 20220119
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons. Teva Pharmaceuticals USA Class II Terminated 20220119
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1 Exela Pharma Sciences LLC Class II Terminated 20220119
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34 Akorn, Inc. Class III Terminated 20220119
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30 Akorn, Inc. Class III Terminated 20220119
Metformin 750 mg Extended Release NDC # 70518-2920-00 RemedyRepack Inc. Class II Terminated 20220119
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. Torrent Pharma Inc. Class II Terminated 20220119
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4 Revive Personal Products Company Class II Ongoing 20220119
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00 Rubicon Research Private Limited Class II Terminated 20220119
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88. SUN PHARMACEUTICAL INDUSTRIES INC Class II Terminated 20220112
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645 RemedyRepack Inc. Class II Terminated 20220112
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50 Ascend Laboratories, LLC Class II Terminated 20220112
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01 Lupin Pharmaceuticals Inc. Class III Terminated 20220112
GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30, Perrigo Company PLC Class II Terminated 20220112
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4 Perrigo Company PLC Class II Terminated 20220112
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4 Perrigo Company PLC Class II Terminated 20220112
amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2 Perrigo Company PLC Class II Terminated 20220112
Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2 Perrigo Company PLC Class II Terminated 20220112
Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, Perrigo Company PLC Class II Terminated 20220112
up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Republic, Perrigo Company PLC Class II Terminated 20220112
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, Perrigo Company PLC Class II Terminated 20220112
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3 Perrigo Company PLC Class II Terminated 20220112
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 Perrigo Company PLC Class II Terminated 20220112
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8 Perrigo Company PLC Class II Terminated 20220112
Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2 Perrigo Company PLC Class II Terminated 20220112
Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6 Perrigo Company PLC Class II Terminated 20220112
allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lakeland, FL 33811, Made in the Czech Republic Perrigo Company PLC Class II Terminated 20220112
Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made in the Czech Republic, Distributed by Meijer Distribution Inc, Grand Rapids, MI 49544. Perrigo Company PLC Class II Terminated 20220112
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9 Perrigo Company PLC Class II Terminated 20220112
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2 Perrigo Company PLC Class II Terminated 20220112
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, Perrigo Company PLC Class II Terminated 20220112
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9 Perrigo Company PLC Class II Terminated 20220112
Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1 Perrigo Company PLC Class II Terminated 20220112