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.
- 2025-03-19FDA-DrugBreckenridge Pharmaceutical, Inc.Class IIDuloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- 2025-03-19FDA-DrugICU Medical, Inc.Class IPOTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
- 2025-03-19FDA-DrugICU Medical, Inc.Class IPOTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
- 2025-03-19FDA-DrugChattem IncClass IIUnisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
- 2025-03-19FDA-DrugAspen Biopharma Labs Pvt., Ltd.Class IIVoriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
CGMP Deviations
- 2025-03-19FDA-DrugAspen Biopharma Labs Pvt., Ltd.Class IILatanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
CGMP Deviations
- 2025-03-19FDA-DrugAspen Biopharma Labs Pvt., Ltd.Class IIChlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
CGMP Deviations
- 2025-03-19FDA-DrugAspen Biopharma Labs Pvt., Ltd.Class IIFinasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
CGMP Deviations
- 2025-03-19FDA-DrugAspen Biopharma Labs Pvt., Ltd.Class IIAlprostadil Container Description: Amber color bottle
CGMP Deviations
- 2025-03-19FDA-DrugAspen Biopharma Labs Pvt., Ltd.Class IIBimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
CGMP Deviations
- 2025-03-19FDA-DrugCareFusion 213, LLCClass IBD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
- 2025-03-19FDA-DrugKowa Pharmaceuticals AmericaClass IIILivalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case
Presence of foreign tablets/capsules
- 2025-03-19FDA-DrugNephron Sterile Compounding Center LLCClass IISodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
- 2025-03-12FDA-DrugZydus Pharmaceuticals (USA) IncClass IINelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Failed Impurities/Degradation Specifications
- 2025-03-12FDA-DrugZydus Pharmaceuticals (USA) IncClass IINelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Failed Impurities/Degradation Specifications
- 2025-03-12FDA-DrugSafecor Health, LLCClass IIMorphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- 2025-03-12FDA-DrugSafecor Health, LLCClass IILorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- 2025-03-12FDA-DrugSafecor Health, LLCClass IIFerrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- 2025-03-12FDA-DrugSafecor Health, LLCClass IISimethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- 2025-03-12FDA-DrugSafecor Health, LLCClass IIErgocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- 2025-03-12FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIMorphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
Failed Dissolution Specifications
- 2025-03-05FDA-DrugTurbare ManufacturingClass IIAvastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
Lack of Assurance of Sterility: due to a quality control process deviation
- 2025-03-05FDA-DrugWuxi Medical lnstrument Factory Co., Ltd.Class IIViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
- 2025-03-05FDA-DrugPadagis US LLCClass IIEstradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
- 2025-02-26FDA-DrugAlvogen, IncClass IFentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- 2025-02-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIAtomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
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: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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