July 9, 2025DrugsFDA
AvKARE recalls Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906
Hazard: Failed Impurity/Degradation Specifications
July 9, 2025DrugsFDA
AvKARE recalls Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905
Hazard: Failed Impurity/Degradation Specifications
July 9, 2025DrugsFDA
Orient Pharma Co., Ltd. Yunlin Plant recalls Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen,
Hazard: Failed Impurities/Degradation Specifications.
July 9, 2025DrugsFDA
Orient Pharma Co., Ltd. Yunlin Plant recalls Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen,
Hazard: Failed Impurities/Degradation Specifications.
July 9, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-cou
Hazard: Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
July 9, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICAL
Hazard: Defective container; blister packaging inadequately sealed.
July 9, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJO
Hazard: Defective container; blister packaging inadequately sealed.
July 9, 2025DrugsFDA
Church & Dwight Inc recalls Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use S
Hazard: Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
July 9, 2025DrugsFDA
Church & Dwight Inc recalls ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216
Hazard: Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
July 9, 2025DrugsFDA
Church & Dwight Inc recalls ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing
Hazard: Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
July 9, 2025DrugsFDA
Tailstorm Health INC recalls LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & E
Hazard: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
July 9, 2025DrugsFDA
Tailstorm Health INC recalls LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block
Hazard: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
July 9, 2025DrugsFDA
Tailstorm Health INC recalls KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only
Hazard: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
July 9, 2025DrugsFDA
Tailstorm Health INC recalls KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, R
Hazard: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
July 9, 2025DrugsFDA
Tailstorm Health INC recalls BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vi
Hazard: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
July 9, 2025DrugsFDA
Tailstorm Health INC recalls LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Ner
Hazard: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
July 2, 2025DrugsFDA
Advanced Pharmaceutical Technology, Inc. recalls TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscula
Hazard: Marketed Without an Approved NDA/ANDA
July 2, 2025DrugsFDA
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex In
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Apotex Corp. recalls Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx onl
Hazard: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
July 2, 2025DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Pfizer Inc. recalls DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, F
Hazard: Discoloration; discolored solution from cracked vials
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Su
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 I
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Su
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewoo
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewoo
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewoo
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Sui
Hazard: Lack of Assurance of Sterility