FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 103 of 348
Moderate Dec 16, 2020
Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI …
Asiaticon, SA de CV
Critical Dec 9, 2020
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
Torrent Pharma Inc
Moderate Dec 9, 2020
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, …
Golden State Medical Supply Inc.
Low Dec 9, 2020
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
Teligent Pharma, Inc.
Moderate Dec 9, 2020
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC…
US Pharmaceuticals Inc.
Moderate Dec 9, 2020
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distribute…
The Harvard Drug Group
Moderate Dec 9, 2020
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend…
Ascend Laboratories LLC
Critical Dec 9, 2020
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cu…
Lohxa LLC
Low Dec 9, 2020
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10…
InvaTech Pharma Solutions, LLC
Critical Dec 9, 2020
REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-…
MPM Medical LLC
Low Dec 2, 2020
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
Teligent Pharma, Inc.
Moderate Dec 2, 2020
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC …
Jubilant Cadista Pharmaceuticals, Inc.
Low Dec 2, 2020
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lak…
Fresenius Kabi USA, LLC
Moderate Dec 2, 2020
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av.…
AA PRODUCTS INC
Moderate Dec 2, 2020
Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health an…
Fusion Health and Vitality LLC
Moderate Dec 2, 2020
Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Ma…
EYWA PHARMA INC
Low Dec 2, 2020
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made…
Heritage Pharmaceuticals Inc
Critical Dec 2, 2020
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL)…
Sunstar Americas, Inc.
Moderate Nov 25, 2020
Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 50…
Albek De Mexico S.A. De C.V.
Low Nov 25, 2020
Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.
Grato Holdings, Inc.
Moderate Nov 25, 2020
DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500…
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactu…
Apotex Corp.
Moderate Nov 25, 2020
DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven,…
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seve…
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788…
Preferred Pharmaceuticals, Inc.
Moderate Nov 25, 2020
Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
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 10…
Albek De Mexico S.A. De C.V.
Moderate Nov 25, 2020
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-…
Hikma Pharmaceuticals USA Inc.
Moderate Nov 25, 2020
DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 954…
Albek De Mexico S.A. De C.V.
Moderate Nov 25, 2020
Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscata…
Ascent Pharmaceuticals, Inc.
Low Nov 25, 2020
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-32…
Teva Pharmaceuticals USA
Moderate Nov 25, 2020
NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Housto…
Albek De Mexico S.A. De C.V.
Moderate Nov 25, 2020
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…
Albek De Mexico S.A. De C.V.
Moderate Nov 25, 2020
MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
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.
Moderate Nov 25, 2020
DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
Milbar Laboratories, Inc.
Moderate Nov 25, 2020
(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Dis…
Milbar Laboratories, Inc.
Moderate Nov 18, 2020
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,…
H & H Remedies, LLC
Moderate Nov 18, 2020
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 4229…
AVKARE Inc.
Moderate Nov 18, 2020
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, …
Teva Pharmaceuticals USA
Moderate Nov 18, 2020
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 Phil…
H & H Remedies, LLC
Moderate Nov 18, 2020
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…
Baxter Healthcare Corporation
Moderate Nov 18, 2020
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 …
H & H Remedies, LLC
Moderate Nov 11, 2020
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 c…
Marksans Pharma Limited