FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 31 of 348
Moderate Nov 15, 2023
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed…
Zydus Pharmaceuticals (USA) Inc
Low Nov 15, 2023
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
AbbVie Inc.
Moderate Nov 15, 2023
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medlin…
MEDLINE INDUSTRIES, LP - Northfield
Low Nov 15, 2023
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 6934…
Zyla Life Sciences US Inc.
Moderate Nov 15, 2023
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Ph…
Glenmark Pharmaceuticals Inc., USA
Critical Nov 15, 2023
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distribu…
Pfizer Inc.
Moderate Nov 8, 2023
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07…
GlaxoSmithKline Consumer Healthcare Holdings LLC
Moderate Nov 8, 2023
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228…
GlaxoSmithKline Consumer Healthcare Holdings LLC
Moderate Nov 8, 2023
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 013…
GlaxoSmithKline Consumer Healthcare Holdings LLC
Low Nov 8, 2023
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, P…
Glenmark Pharmaceuticals Inc., USA
Moderate Nov 8, 2023
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC:…
GlaxoSmithKline Consumer Healthcare Holdings LLC
Moderate Nov 8, 2023
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx O…
Padagis US LLC
Moderate Nov 8, 2023
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactu…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Nov 8, 2023
Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC#…
Safecor Health, LLC
Moderate Nov 8, 2023
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufact…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Nov 8, 2023
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07…
GlaxoSmithKline Consumer Healthcare Holdings LLC
Moderate Nov 8, 2023
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07…
GlaxoSmithKline Consumer Healthcare Holdings LLC
Low Nov 8, 2023
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmac…
Edenbridge Pharmaceuticals, LLC
Moderate Nov 8, 2023
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059…
GlaxoSmithKline Consumer Healthcare Holdings LLC
Low Nov 1, 2023
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, …
Denver Solutions, LLC DBA Leiters Health
Critical Nov 1, 2023
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Biomic Sciences, LLC dba ION Intelligence of Nature
Low Nov 1, 2023
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, N…
Denver Solutions, LLC DBA Leiters Health
Moderate Nov 1, 2023
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Biomic Sciences, LLC dba ION Intelligence of Nature
Low Nov 1, 2023
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, …
Denver Solutions, LLC DBA Leiters Health
Moderate Nov 1, 2023
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
Biomic Sciences, LLC dba ION Intelligence of Nature
Low Nov 1, 2023
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.…
West-Ward Columbus Inc
Moderate Oct 25, 2023
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Park…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawa…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corpora…
Baxter Healthcare Corporation
Moderate Oct 25, 2023
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharm…
Pine Pharmaceuticals, LLC
Critical Oct 25, 2023
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
KVK-Tech, Inc.
Moderate Oct 25, 2023
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals …
Pine Pharmaceuticals, LLC
Critical Oct 25, 2023
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, …
Church & Dwight Inc
Low Oct 25, 2023
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, …
Imprimis NJOF, LLC
Moderate Oct 25, 2023
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 1…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 …
Pine Pharmaceuticals, LLC
Low Oct 25, 2023
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cr…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Oct 25, 2023
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkwa…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 1…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355…
Pine Pharmaceuticals, LLC
Moderate Oct 25, 2023
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riv…
Pine Pharmaceuticals, LLC
Critical Oct 25, 2023
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. …
VistaPharm LLC
Moderate Oct 25, 2023
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Dollar Tree Distribution, Inc.
Critical Oct 18, 2023
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 7…
Scynexis, Inc.