Browse Drug Recalls
1,110 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,110 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,110 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 10, 2025 | Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz ... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT.... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Sep 12, 2025 | Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Aug 28, 2025 | Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil | Class I | Green Lumber Holdings, LLC |
| Jul 1, 2025 | PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated... | Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identifi... | Class II | Central Admixture Pharmacy Services, Inc (CAPS)... |
| Apr 28, 2025 | temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by:... | CGMP Deviations | Class II | Siddha Flower Essences, LLC. |
| Apr 18, 2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufacture... | cGMP Deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 15, 2025 | Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), ... | Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are ... | Class II | Nubratori, Inc |
| Mar 31, 2025 | 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL... | Presence of Particulate Matter | Class II | B. Braun Medical Inc |
| Mar 7, 2025 | Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister c... | Defective Container: blister packs not properly sealed resulting in tablets being loose in the ca... | Class II | ASEGUA THERAPEUTICS LLC |
| Mar 5, 2025 | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorp... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL si... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx ... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Dec 16, 2024 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Di... | Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with und... | Class I | SHOPPERS- PLAZA |
| Nov 22, 2024 | 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your R... | CGMP Deviations: Inconsistency in the water systems. | Class II | Generitech Corporation |
| Nov 4, 2024 | ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomM... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Nov 4, 2024 | PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distribut... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Nov 4, 2024 | VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Dist... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Nov 4, 2024 | ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Oct 8, 2024 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, | Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class II | C & A Naturistics |
| Sep 24, 2024 | Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Ma... | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in... | Class II | Nivagen Pharmaceuticals Inc |
| Sep 19, 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: Presence of glass particle. | Class I | Gilead Sciences, Inc. |
| Sep 18, 2024 | Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sd... | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone ... | Class I | 123Herbals |
| Aug 28, 2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML... | Microbial contamination of non-sterile Products - | Class II | PREQUEL SKIN |
| Aug 8, 2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... | Failed Impurities/Degradation Specifications - at 18-month Stability testing | Class II | Preferred Pharmaceuticals, Inc. |
| Jul 24, 2024 | 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... | Presence of Particulate Matter | Class I | B. Braun Medical Inc |
| Jul 18, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... | Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Dicl... | Class I | MAIN PRODUCTS INC |
| Jul 12, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared D... | Class I | SoloVital |
| Jun 24, 2024 | SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, ... | Sub-potent Drug | Class III | Neilmed Pharmaceuticals Inc |
| Jun 12, 2024 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... | Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing... | Class II | PACIRA PHARMACEUTICALS INC |
| May 22, 2024 | OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 3... | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... | Class II | MexHealth LLC |
| May 20, 2024 | Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San F... | Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo ... | Class II | Genentech, Inc. |
| May 13, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottl... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Golden State Medical Supply Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel... | Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ... | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Preferred Pharmaceuticals, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),... | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe... | Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe... | Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 7, 2024 | Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectab... | Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. | Class II | PACIRA PHARMACEUTICALS INC |
| Mar 22, 2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... | Lack of assurance of sterility: bags have the potential to leak.. | Class II | B. Braun Medical Inc |
| Mar 19, 2024 | GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres L... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.