FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 60 of 348
Moderate Aug 31, 2022
MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 C…
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30…
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
ALKA SELTZER EXTRA STRENGTH 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JA…
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL O…
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2…
Family Dollar Stores, Llc.
Moderate Aug 31, 2022
MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores, Llc.
Moderate Aug 24, 2022
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Lupin Pharmaceuticals Inc.
Moderate Aug 24, 2022
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare …
Zydus Pharmaceuticals (USA) Inc
Moderate Aug 24, 2022
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
Aire-Master of America Inc
Moderate Aug 24, 2022
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, …
Nephron Sterile Compounding Center LLC
Moderate Aug 24, 2022
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Ne…
Nephron Sterile Compounding Center LLC
Moderate Aug 24, 2022
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Akorn, Inc
Moderate Aug 24, 2022
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
Aire-Master of America Inc
Moderate Aug 24, 2022
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Aire-Master of America Inc
Low Aug 24, 2022
Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pha…
Akron Pharma, Inc.
Moderate Aug 24, 2022
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12t…
Nephron Sc Inc
Moderate Aug 24, 2022
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourci…
Nephron Sterile Compounding Center LLC
Low Aug 24, 2022
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for He…
HERON THERAPEUTICS, INC.
Low Aug 24, 2022
Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactur…
Akron Pharma, Inc.
Moderate Aug 24, 2022
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in…
Nephron Sterile Compounding Center LLC
Moderate Aug 24, 2022
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
Aire-Master of America Inc
Moderate Aug 24, 2022
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Hea…
Baxter Healthcare Corporation
Critical Aug 24, 2022
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Co…
MEDEK LLC
Low Aug 24, 2022
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad…
Amerisource Health Services LLC
Moderate Aug 24, 2022
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufac…
Aire-Master of America Inc
Moderate Aug 24, 2022
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bol…
Aire-Master of America Inc
Moderate Aug 17, 2022
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC …
SterRx, LLC
Low Aug 17, 2022
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Teva Pharmaceuticals USA Inc
Moderate Aug 17, 2022
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharm…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton …
Hikma Pharmaceuticals USA Inc.
Moderate Aug 17, 2022
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Ste…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 06…
Hikma Pharmaceuticals USA Inc.
Moderate Aug 17, 2022
Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 6777…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per…
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 17, 2022
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# ND…
Hikma Pharmaceuticals USA Inc.
Moderate Aug 17, 2022
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: St…
Strides Pharma Inc.
Moderate Aug 17, 2022
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla U…
CIPLA
Low Aug 17, 2022
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
AVKARE Inc.