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.
- 2024-12-18FDA-DrugViatris IncClass IILevothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugViatris IncClass IILevothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Superpotent Drug and Subpotent Drug: potency failures obtained
- 2024-12-18FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIJavygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.
Failed Impurities/Degradation Specifications
- 2024-12-18FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIHylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
cGMP Deviations: Temperature excursion
- 2024-12-18FDA-DrugLNK International, Inc.Class IIKirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81
CGMP Deviations: Released product should have been rejected.
- 2024-12-18FDA-DrugFDC LimitedClass IITimolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- 2024-12-18FDA-DrugBiocompatibles UK, Ltd.Class IIIVarithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
- 2024-12-11FDA-DrugLannett Company Inc.Class IILisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- 2024-12-11FDA-DrugGeneritech CorporationClass II10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.
CGMP Deviations: Inconsistency in the water systems.
- 2024-12-11FDA-DrugAvKAREClass IICinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- 2024-12-11FDA-DrugAvKAREClass IICinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- 2024-12-11FDA-DrugAvKAREClass IICinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- 2024-12-11FDA-DrugRising Pharma Holding, Inc.Class IIDuloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- 2024-12-11FDA-DrugRising Pharma Holding, Inc.Class IIDuloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- 2024-12-11FDA-DrugRising Pharma Holding, Inc.Class IIDuloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- 2024-12-11FDA-DrugAvKAREClass IISunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Labeling: Label Mix-Up
- 2024-12-11FDA-DrugAvKAREClass IISunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Labeling: Label Mix-Up
- 2024-12-11FDA-DrugZydus Pharmaceuticals (USA) IncClass IIIEsomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
Labeling: Not Elsewhere Classified - Wrong NDC number
- 2024-12-11FDA-DrugAmerisource Health Services LLCClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- 2024-12-11FDA-DrugAmerisource Health Services LLCClass IIDuloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- 2024-12-11FDA-DrugAmerisource Health Services LLCClass IIDuloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- 2024-12-11FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIDiltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- 2024-12-11FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIDiltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- 2024-12-11FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIDiltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- 2024-12-11FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIDiltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- 2024-12-11FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIDiltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- 2024-12-11FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIDiltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- 2024-12-11FDA-DrugMidlab IncorporatedClass IICompliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670
cGMP Deviations: Out of specification results for micro in hand soap products.
- 2024-12-11FDA-DrugMidlab IncorporatedClass IIGenuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
cGMP Deviations: Out of specification results for micro in hand soap products.
- 2024-12-11FDA-DrugMidlab IncorporatedClass IIROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
cGMP Deviations: Out of specification results for micro in hand soap products.
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