Category
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.
- 2025-06-04FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IICarvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- 2025-06-04FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IICarvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- 2025-06-04FDA-DrugAlembic Pharmaceuticals LimitedClass IIBromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Failed Impurities/Degradation Specifications
- 2025-05-28FDA-DrugKVK Tech, Inc.Class IIPhentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.
cGMP deviations
- 2025-05-28FDA-DrugKVK Tech, Inc.Class IIIndomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
cGMP deviations
- 2025-05-28FDA-DrugAsttraZeneca Pharmaceuticals LPClass IIAirsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .
Defective delivery system
- 2025-05-28FDA-DrugZydus Pharmaceuticals (USA) IncClass IIEsomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- 2025-05-28FDA-DrugZydus Pharmaceuticals (USA) IncClass IIEsomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- 2025-05-28FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IINature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IINature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IINature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIMaximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIMaximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIMaximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIMaximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IICinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIRapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIRapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIOptim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIKOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIKOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIKingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IICURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IICURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
CGMP Deviations
- 2025-05-28FDA-DrugKENIL HEALTHCARE PRIVATE LIMITEDClass IIArtridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.
CGMP Deviations
- 2025-05-21FDA-DrugEmpower Clinic Services, LLC dba Empower PharmacyClass IITestosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
Lack of Assurance of Sterility
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