March 19, 2025DrugsFDA
Sigan Industries Group Inc. recalls Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 2
Hazard: Chemical Contamination: Presence of benzene
March 19, 2025DrugsFDA
Denison Pharmaceuticals, LLC recalls Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEA
Hazard: Chemical Contamination: Presence of benzene.
March 19, 2025DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Servi
Hazard: Presence of Particulate Matter
March 19, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Ma
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
March 19, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. M
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
March 19, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. M
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
March 19, 2025DrugsFDA
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest,
Hazard: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
March 19, 2025DrugsFDA
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lak
Hazard: 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.
March 19, 2025DrugsFDA
Chattem Inc recalls Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flav
Hazard: CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
March 19, 2025DrugsFDA
Aspen Biopharma Labs Pvt., Ltd. recalls Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied
Hazard: CGMP Deviations
March 19, 2025DrugsFDA
Aspen Biopharma Labs Pvt., Ltd. recalls Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Hazard: CGMP Deviations
March 19, 2025DrugsFDA
Aspen Biopharma Labs Pvt., Ltd. recalls Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover fo
Hazard: CGMP Deviations
March 19, 2025DrugsFDA
Aspen Biopharma Labs Pvt., Ltd. recalls Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and
Hazard: CGMP Deviations
March 19, 2025DrugsFDA
Aspen Biopharma Labs Pvt., Ltd. recalls Alprostadil Container Description: Amber color bottle
Hazard: CGMP Deviations
March 19, 2025DrugsFDA
Aspen Biopharma Labs Pvt., Ltd. recalls Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed i
Hazard: CGMP Deviations
March 19, 2025DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient P
Hazard: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
March 19, 2025DrugsFDA
Kowa Pharmaceuticals America recalls Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA
Hazard: Presence of foreign tablets/capsules
March 19, 2025DrugsFDA
Nephron Sterile Compounding Center LLC recalls Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Colu
Hazard: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
March 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Sing
Hazard: Failed Impurities/Degradation Specifications
March 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Sing
Hazard: Failed Impurities/Degradation Specifications
March 12, 2025DrugsFDA
Safecor Health, LLC recalls Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safeco
Hazard: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
March 12, 2025DrugsFDA
Safecor Health, LLC recalls Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg b
Hazard: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
March 12, 2025DrugsFDA
Safecor Health, LLC recalls Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by:
Hazard: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
March 12, 2025DrugsFDA
Safecor Health, LLC recalls Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Col
Hazard: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
March 12, 2025DrugsFDA
Safecor Health, LLC recalls Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mf
Hazard: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
March 12, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., N
Hazard: Failed Dissolution Specifications
March 5, 2025DrugsFDA
Turbare Manufacturing recalls Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single U
Hazard: Lack of Assurance of Sterility: due to a quality control process deviation
March 5, 2025DrugsFDA
Wuxi Medical lnstrument Factory Co., Ltd. recalls ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carto
Hazard: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
March 5, 2025DrugsFDA
Padagis US LLC recalls Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham,
Hazard: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
February 26, 2025DrugsFDA
Alvogen, Inc recalls Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed
Hazard: Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.