July 30, 2025DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc.,
Hazard: CGMP Deviations; potential temperature excursions due to transit delays
July 30, 2025DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks,
Hazard: CGMP Deviations; potential temperature excursions due to transit delays
July 30, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida
Hazard: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
July 30, 2025DrugsFDA
Imprimis NJOF, LLC recalls Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per ca
Hazard: Sub-Potent Drug: Subpotent assay results during stability testing.
July 30, 2025DrugsFDA
Imprimis NJOF, LLC recalls Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 Wes
Hazard: Sub-Potent Drug: Subpotent assay results during stability testing.
July 23, 2025DrugsFDA
A.P. Deauville, LLC recalls Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL
Hazard: CGMP Deviations
July 23, 2025DrugsFDA
A.P. Deauville, LLC recalls Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1
Hazard: CGMP Deviations
July 23, 2025DrugsFDA
A.P. Deauville, LLC recalls Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville,
Hazard: CGMP Deviations
July 23, 2025DrugsFDA
Ascend Laboratories, LLC recalls Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,
Hazard: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
July 23, 2025DrugsFDA
Ascend Laboratories, LLC recalls Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,
Hazard: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
July 23, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,
Hazard: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
July 23, 2025DrugsFDA
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles recalls PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection,
Hazard: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
July 23, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Li
Hazard: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, In
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc.
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc
Hazard: Subpotent Drug: Assay below the approved specification
July 23, 2025DrugsFDA
Qualgen, LLC recalls Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edm
Hazard: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
July 23, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Bru
Hazard: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
July 16, 2025DrugsFDA
KABANA SKIN CARE recalls In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingre
Hazard: cGMP deviations
July 16, 2025DrugsFDA
KABANA SKIN CARE recalls GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Fre
Hazard: cGMP deviations
July 16, 2025DrugsFDA
KABANA SKIN CARE recalls Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made
Hazard: cGMP deviations
July 16, 2025DrugsFDA
KABANA SKIN CARE recalls B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for
Hazard: cGMP deviations
July 16, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. M
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
July 16, 2025DrugsFDA
Macleods Pharmaceuticals Ltd recalls Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by
Hazard: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
July 9, 2025DrugsFDA
Sandoz Inc recalls Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Ma
Hazard: Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
July 9, 2025DrugsFDA
Sandoz Inc recalls Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by S
Hazard: Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin