Browse Drug Recalls
1,076 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,076 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 1,076 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Mar 19, 2024 | HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, 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 | ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving ... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Samurai-X Honey 6800, UPC 2 56891 27553 3. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 6, 2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... | Class II | B. Braun Medical Inc |
| Feb 14, 2024 | Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays,... | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex | Class II | Golden State Medical Supply Inc. |
| Feb 9, 2024 | Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076... | Failed Dissolution Specifications: results slightly under spec at at 9-months. | Class III | Stason Pharmaceuticals, Inc. |
| Jan 16, 2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| Jan 16, 2024 | Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flav... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| Jan 12, 2024 | Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Dec 13, 2023 | Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... | CGMP Deviations: Stability data does not support expiry date. | Class II | Private Label Partners, Inc. |
| Nov 13, 2023 | KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Sus... | Failed Impurities/Degradation Specifications | Class II | KINDER FARMS LLC |
| Nov 13, 2023 | KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral ... | Failed Impurities/Degradation Specifications | Class II | KINDER FARMS LLC |
| Nov 10, 2023 | PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Nov 10, 2023 | PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-73... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Nov 10, 2023 | PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-73... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Sep 21, 2023 | HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx o... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe,... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 793... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL s... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total V... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syring... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services 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.