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.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-26FDA-DrugProvepharm Inc.Class IPhenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
Presence of Particulate Matter.
- 2025-02-26FDA-DrugAvKAREClass IISilodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
- 2025-02-26FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IILorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- 2025-02-26FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IILorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- 2025-02-26FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IILorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- 2025-02-26FDA-DrugFagron Compounding ServicesClass IIfentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Lack of Assurance of Sterility
- 2025-02-19FDA-DrugAvKAREClass IIIrbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Out of Specification for Dissolution
- 2025-02-12FDA-DrugENDO USA, Inc.Class IAdrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
- 2025-02-12FDA-DrugPAI Holdings, LLC. dba Pharmaceutical Associates IncClass IIIGuaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
Superpotent; sodium benzoate preservative
- 2025-02-12FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IIPotassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
Failed Dissolution Specifications.
- 2025-02-12FDA-DrugSKY PACKAGINGClass IIHydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
Failed Impurities/Degradation Specifications
- 2025-02-12FDA-DrugSKY PACKAGINGClass IIHydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
Failed Impurities/Degradation Specifications
- 2025-02-12FDA-DrugTeva Pharmaceuticals USA, IncClass IIGranix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
- 2025-02-12FDA-DrugRemedyRepack Inc.Class IICarvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- 2025-02-12FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IICarvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- 2025-02-12FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IICarvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- 2025-02-12FDA-DrugFDC LimitedClass IITimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
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.
- 2025-02-05FDA-DrugMcKessonClass IIInflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
- 2025-02-05FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IIDuloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
- 2025-02-05FDA-DrugAstellas Pharma US Inc.Class IPrograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- 2025-02-05FDA-DrugAstellas Pharma US Inc.Class IAstagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
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