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.
- 2025-09-17FDA-DrugAtlantic Management Resources Ltd.Class IINeuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01
cGMP violations
- 2025-09-17FDA-DrugSandoz IncClass IICiprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67
Temperature Abuse
- 2025-09-17FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- 2025-09-17FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- 2025-09-17FDA-DrugZydus Pharmaceuticals (USA) IncClass IISuccinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
- 2025-09-17FDA-DrugWorld Perfumes Inc.Class IIIodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01
Defective Container: broken or leaking bottles.
- 2025-09-17FDA-DrugBreckenridge Pharmaceutical, Inc.Class IIDuloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
- 2025-09-17FDA-DrugExela Pharma Sciences LLCClass II4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
- 2025-09-10FDA-DrugB BRAUN MEDICAL INCClass I0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Presence of Particulate Matter.
- 2025-09-10FDA-DrugB BRAUN MEDICAL INCClass ILactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Presence of Particulate Matter
- 2025-09-10FDA-DrugAmneal Pharmaceuticals, LLCClass IIchlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- 2025-09-10FDA-DrugAmneal Pharmaceuticals, LLCClass IIchlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- 2025-09-10FDA-DrugAmneal Pharmaceuticals, LLCClass IIchlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- 2025-09-10FDA-DrugAmneal Pharmaceuticals, LLCClass IIchlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- 2025-09-10FDA-DrugAmneal Pharmaceuticals, LLCClass IISulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- 2025-09-10FDA-DrugIMMUNOCORE, LLCClass IIKIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
Subpotent Drug
- 2025-09-10FDA-DrugDermaRite Industries, LLCClass IPeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
- 2025-09-10FDA-DrugDermaRite Industries, LLCClass IKleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
- 2025-09-10FDA-DrugDermaRite Industries, LLCClass IDermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
- 2025-09-10FDA-DrugDermaRite Industries, LLCClass IDermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
- 2025-09-10FDA-DrugBoothwyn Pharmacy LLCClass IISemaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Subpotent Drug
- 2025-09-10FDA-DrugBoothwyn Pharmacy LLCClass IISemaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Subpotent Drug
- 2025-09-10FDA-DrugBoothwyn Pharmacy LLCClass IIIFluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Subpotent Drug
- 2025-09-10FDA-DrugBoothwyn Pharmacy LLCClass IISemaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Subpotent Drug
- 2025-09-03FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IIRITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- 2025-09-03FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IIGood Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- 2025-09-03FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IIH-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- 2025-09-03FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IIReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- 2025-09-03FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IICURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- 2025-09-03FDA-DrugMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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