Drug and pharmaceutical recalls

17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2023-11-15FDA-DrugZyla Life Sciences US Inc.Class III
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: 69344-213-11
Sub-potent Drug: Lower potency than labeled.
2023-11-15FDA-DrugVistaPharm LLCClass III
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
2023-11-15FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Failed Dissolution Specifications: Out of specification for dissolution.
2023-11-15FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass II
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
2023-11-15FDA-DrugAmneal Pharmaceuticals of New York, LLCClass II
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Failed Dissolution Specifications
2023-11-15FDA-DrugTaro Pharmaceuticals Inc.Class III
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
2023-11-15FDA-DrugAbbVie Inc.Class III
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
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
2023-11-15FDA-DrugPAR Sterile Products LLCClass II
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
2023-11-15FDA-DrugDr. Reddy's Laboratories, Inc.Class II
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
2023-11-08FDA-DrugGlenmark Pharmaceuticals Inc., USAClass III
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Failed Impurities/Degradation Specifications
2023-11-08FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass II
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, 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 62756-590-88
Failed Impurities/Degradation Specifications.
2023-11-08FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass II
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, 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 62756-589-88
Failed Impurities/Degradation Specifications.
2023-11-08FDA-DrugSafecor Health, LLCClass II
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# 48433-230-15
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
2023-11-08FDA-DrugPadagis US LLCClass II
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 Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
2023-11-08FDA-DrugEdenbridge Pharmaceuticals, LLCClass III
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
Subpotent Drug
2023-11-08FDA-DrugGlaxoSmithKline Consumer Healthcare Holdings LLCClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
2023-11-08FDA-DrugGlaxoSmithKline Consumer Healthcare Holdings LLCClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
2023-11-08FDA-DrugGlaxoSmithKline Consumer Healthcare Holdings LLCClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
2023-11-08FDA-DrugGlaxoSmithKline Consumer Healthcare Holdings LLCClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
2023-11-08FDA-DrugGlaxoSmithKline Consumer Healthcare Holdings LLCClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
2023-11-08FDA-DrugGlaxoSmithKline Consumer Healthcare Holdings LLCClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
2023-11-08FDA-DrugGlaxoSmithKline Consumer Healthcare Holdings LLCClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
2023-11-01FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass III
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, NDC 71449-029-68.
Labeling: Not Elsewhere Classified
2023-11-01FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass III
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, NDC 71449-028-68.
Labeling: Not Elsewhere Classified
2023-11-01FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass III
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, Englewood, CO 80112, NDC 71449-157-70
Labeling: Not Elsewhere Classified
2023-11-01FDA-DrugBiomic Sciences, LLC dba ION Intelligence of NatureClass II
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Microbial contamination of Non-Sterile Products
2023-11-01FDA-DrugBiomic Sciences, LLC dba ION Intelligence of NatureClass II
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
Microbial contamination of Non-Sterile Products
2023-11-01FDA-DrugBiomic Sciences, LLC dba ION Intelligence of NatureClass I
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Microbial contamination of Non-Sterile Products
2023-11-01FDA-DrugWest-Ward Columbus IncClass III
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
2023-10-25FDA-DrugPine Pharmaceuticals, LLCClass II
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 Riverwalk Parkway, Tonawanda, NY 14150.
Lack of Assurance of Sterility

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