Drug Recalls

2,051 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 601–650 of 2,051

Drug Recall · December 26, 2025
GOLD STAR DISTRIBUTION INC
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Drug Recall · December 26, 2025
GOLD STAR DISTRIBUTION INC
Benadryl, 25'S 2PK Box, UPC 815556020316
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II
Drug Recall · December 22, 2025
Cipla USA, Inc.
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Failed PH Specifications
Class III
Drug Recall · December 22, 2025
Baxter Healthcare Corporation
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Class II
Drug Recall · December 22, 2025
HANDELNINE GLOBAL LLC
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
CGMP Deviations: product found to contain lead.
Class I
Drug Recall · December 19, 2025
Novo Nordisk Inc.
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plain
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II
Drug Recall · December 19, 2025
Sato Pharmaceutical Co., Ltd
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Failed Disintegration Specifications: above the time expected.
Class II
Drug Recall · December 19, 2025
Zydus Pharmaceuticals (USA) Inc
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class III
Drug Recall · December 19, 2025
Novo Nordisk Inc.
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Pla
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II
Drug Recall · December 18, 2025
Imprimis NJOF, LLC
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.
Presence of particulate matter - Glass like particles.
Class II
Drug Recall · December 18, 2025
Imprimis NJOF, LLC
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Presence of particulate matter - Glass like particles.
Class II
Drug Recall · December 18, 2025
Imprimis NJOF, LLC
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Presence of particulate matter - Glass like particles.
Class II
Drug Recall · December 17, 2025
CareFusion 213, LLC
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
Lack of Assurance of Sterlity
Class II
Drug Recall · December 16, 2025
SpecGx, LLC
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II
Drug Recall · December 16, 2025
SpecGx, LLC
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 05
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II
Drug Recall · December 16, 2025
Alembic Pharmaceuticals Limited
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals,
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III
Drug Recall · December 15, 2025
NOVADOZ PHARMACEUTICALS LLC
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, N
Failed Impurities/Degradation Specifications
Class III
Drug Recall · December 15, 2025
StuffbyNainax
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Class I
Drug Recall · December 12, 2025
Merck Sharp & Dohme LLC
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Lim
Presence of particulate matter: potential presence of metal particulates in the product.
Class II
Drug Recall · December 12, 2025
Medinatura New Mexico, inc.
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I
Drug Recall · December 12, 2025
Medinatura New Mexico, inc.
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I
Drug Recall · December 12, 2025
Merck Sharp & Dohme LLC
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Org
Presence of particulate matter: potential presence of metal particulates in the product.
Class II
Drug Recall · December 9, 2025
SUN PHARMA /TARO
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Class II
Drug Recall · December 8, 2025
Signature Formulations, LLC
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
cGMP Deviations
Class II
Drug Recall · December 8, 2025
Signature Formulations, LLC
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
cGMP Deviations
Class II
Drug Recall · November 26, 2025
Golden State Medical Supply Inc.
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Presence of Foreign Tablets/Capsules
Class II
Drug Recall · November 26, 2025
SOMERSET THERAPEUTICS LLC
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single d
Subpotent product:out of specification assay results observed during long term stability testing.
Class III
Drug Recall · November 26, 2025
SOMERSET THERAPEUTICS LLC
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL
Subpotent product:out of specification assay results observed during long term stability testing.
Class III
Drug Recall · November 26, 2025
Winder Laboratories, LLC
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class III
Drug Recall · November 26, 2025
SOMERSET THERAPEUTICS LLC
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-do
Subpotent product:out of specification assay results observed during long term stability testing.
Class III
Drug Recall · November 26, 2025
SUN PHARMACEUTICAL INDUSTRIES INC
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, I
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class III
Drug Recall · November 24, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmac
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II
Drug Recall · November 24, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmac
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II
Drug Recall · November 21, 2025
Glenmark Pharmaceuticals Inc., USA
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-8
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class III
Drug Recall · November 20, 2025
Fagron Compounding Services
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 871
Incorrect Product Formulation
Class II
Drug Recall · November 18, 2025
Glenmark Pharmaceuticals Inc., USA
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy,
Cross Contamination with Other Products
Class III
Drug Recall · November 17, 2025
Preferred Pharmaceuticals, Inc.
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II
Drug Recall · November 14, 2025
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II
Drug Recall · November 14, 2025
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II
Drug Recall · November 14, 2025
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II
Drug Recall · November 13, 2025
Lupin Pharmaceuticals Inc.
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Man
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II
Drug Recall · November 12, 2025
Medical Products Laboratories, Inc.
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class II
Drug Recall · November 11, 2025
Dr. Reddy's Laboratories, Inc.
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class III
Drug Recall · November 7, 2025
Teva Pharmaceuticals USA, Inc
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, I
Defective Container - A defect in the side-seal which allows leakage of product.
Class III
Drug Recall · November 6, 2025
Fresenius Kabi USA, LLC
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class I
Drug Recall · November 5, 2025
Lupin Pharmaceuticals Inc.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Defective container - seal not adhering to bottles
Class II
Drug Recall · October 31, 2025
Novocol Pharmaceutical of Canada, Inc.
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply
Defective container: cracked/broken cartridges
Class II
Drug Recall · October 31, 2025
Novocol Pharmaceutical of Canada, Inc.
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of
Defective container: cracked/broken cartridges
Class II
Drug Recall · October 31, 2025
Blossom Pharmaceuticals
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
cGMP deviations
Class II
Drug Recall · October 31, 2025
Blossom Pharmaceuticals
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
cGMP deviations
Class II