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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
DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627 Milbar Laboratories, Inc. Class II Terminated 20201125
NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3 Albek De Mexico S.A. De C.V. Class II Ongoing 20201125
Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597 Albek De Mexico S.A. De C.V. Class II Ongoing 20201125
Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610 Albek De Mexico S.A. De C.V. Class II Ongoing 20201125
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6 Albek De Mexico S.A. De C.V. Class II Ongoing 20201125
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5 Albek De Mexico S.A. De C.V. Class II Ongoing 20201125
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc. Preferred Pharmaceuticals, Inc. Class II Terminated 20201125
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10 Baxter Healthcare Corporation Class II Terminated 20201118
Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663 H & H Remedies, LLC Class II Terminated 20201118
White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663 H & H Remedies, LLC Class II Terminated 20201118
Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663 H & H Remedies, LLC Class II Terminated 20201118
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12 AVKARE Inc. Class II Terminated 20201118
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22. Teva Pharmaceuticals USA Class II Terminated 20201118
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77 Zydus Pharmaceuticals (USA) Inc Class II Terminated 20201111
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77 Zydus Pharmaceuticals (USA) Inc Class II Terminated 20201111
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01 Nostrum Laboratories Inc Class II Ongoing 20201111
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01 Nostrum Laboratories Inc Class II Ongoing 20201111
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32 Jubilant Cadista Pharmaceuticals, Inc. Class III Terminated 20201111
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92 Aurobindo Pharma USA Inc. Class III Terminated 20201111
Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310 Teligent Pharma, Inc. Class III Terminated 20201111
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01 Marksans Pharma Limited Class II Terminated 20201111
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50 Marksans Pharma Limited Class II Terminated 20201111
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60 PD-Rx Pharmaceuticals, Inc. Class II Terminated 20201111
metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 PD-Rx Pharmaceuticals, Inc. Class II Terminated 20201111
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90 Direct Rx Class II Terminated 20201111
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131 Denton Pharma, Inc. Class II Ongoing 20201111
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30 Denton Pharma, Inc. Class II Ongoing 20201111
Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 Medichem S.A. Class II Terminated 20201111
N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023 Jarrow Formulas Inc Class II Terminated 20201104
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15 Bausch Health Companies, Inc. Class II Terminated 20201104
Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01 Boehringer Ingelheim Pharmaceuticals, Inc. Class II Terminated 20201104
Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01 Boehringer Ingelheim Pharmaceuticals, Inc. Class II Terminated 20201104
Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01 Boehringer Ingelheim Pharmaceuticals, Inc. Class II Terminated 20201104
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00 RemedyRepack Inc. Class II Terminated 20201104
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Mylan Pharmaceuticals Inc. Class III Terminated 20201028
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10 ANI Pharmaceuticals, Inc. Class III Terminated 20201028
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10 ANI Pharmaceuticals, Inc. Class III Terminated 20201028
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10 ANI Pharmaceuticals, Inc. Class III Terminated 20201028
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10 ANI Pharmaceuticals, Inc. Class III Terminated 20201028
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10 ANI Pharmaceuticals, Inc. Class III Terminated 20201028
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10 ANI Pharmaceuticals, Inc. Class III Terminated 20201028
Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22 eVenus Pharmaceutical Laboratories Class III Terminated 20201028
Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427. Genesis Partnership Company SA Class II Ongoing 20201028
Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250. Genesis Partnership Company SA Class II Ongoing 20201028
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427. Genesis Partnership Company SA Class II Ongoing 20201028
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773. Genesis Partnership Company SA Class II Ongoing 20201028
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016. Genesis Partnership Company SA Class II Ongoing 20201028
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01 Acella Pharmaceuticals, LLC Class I Terminated 20201028
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01 Acella Pharmaceuticals, LLC Class I Terminated 20201028
Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC 8 50016 92319 6, NDC 70108-043-01); Distributed by Ashtel Studios Inc., Ontario, CA 91761 ASHTEL STUDIOS, INC. Class I Terminated 20201021