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 |
|---|---|---|---|---|
| Apr 26, 2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 20, 2023 | Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per ... | Labeling: Typographical error on the upper left-hand side of the box and individual patch label t... | Class III | Bryant Ranch Prepack, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-75... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharma... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Acco... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accor... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: ... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufacture... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (ND... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC ... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Acc... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accor... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: ... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactu... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 1, 2023 | Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dext... | Subpotent Drug: low Anti-Factor IIa potency. | Class II | B. Braun Medical Inc |
| Feb 13, 2023 | PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-c... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Volt Candy Wholesale Club |
| Jan 16, 2023 | Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord He... | Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a... | Class II | Preferred Pharmaceuticals, Inc. |
| Jan 4, 2023 | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx ... | Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dis... | Class III | Intersect ENT, Inc. |
| Dec 8, 2022 | Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/... | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Dec 8, 2022 | Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) In... | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Oct 18, 2022 | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton contain... | Defective Delivery System: Commercial implants do not meet the filed specification for the intend... | Class III | Genentech Inc |
| Oct 13, 2022 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-... | Failed Stability Specifications | Class III | Aadi Bioscience |
| Oct 6, 2022 | Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323... | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... | Class II | Golden State Medical Supply Inc. |
| Oct 6, 2022 | Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Pat... | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... | Class II | Golden State Medical Supply Inc. |
| Sep 29, 2022 | Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: AL... | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets | Class I | Golden State Medical Supply Inc. |
| Aug 15, 2022 | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... | Class II | Ultra Chem Labs Corp |
| Aug 15, 2022 | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... | Class II | Ultra Chem Labs Corp |
| Aug 2, 2022 | Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam ... | Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of ... | Class III | HERON THERAPEUTICS, INC. |
| Jun 27, 2022 | Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharm... | Subpotent and Superpotent Drug | Class I | Valor Compounding Pharmacy, Inc DBA Valor Comp... |
| Jun 17, 2022 | Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx ... | Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... | Class I | Bryant Ranch Prepack, Inc. |
| Jun 17, 2022 | Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx ... | Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... | Class I | Bryant Ranch Prepack, Inc. |
| Jun 10, 2022 | Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en ... | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... | Class I | Latin Foods Market |
| Jun 9, 2022 | SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, ... | Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain ... | Class I | Green Pharmaceuticals, Inc. |
| May 23, 2022 | Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Su... | Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). | Class I | Akcea Therapeutics, Inc. |
| May 3, 2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Preferred Pharmaceuticals, Inc. |
| May 3, 2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5,... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Preferred Pharmaceuticals, Inc. |
| May 2, 2022 | MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution,... | Defective container: loose crimp defect, potential loss of container integrity. | Class II | Amgen, Inc. |
| Apr 15, 2022 | Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... | Subpotent drug | Class I | Valor Compounding Pharmacy, Inc DBA Valor Comp... |
| Apr 15, 2022 | Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... | Subpotent drug | Class I | Valor Compounding Pharmacy, Inc DBA Valor Comp... |
| Apr 12, 2022 | Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, I... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 29, 2022 | Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manu... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared silde... | Class I | Pink Toyz |
| Mar 28, 2022 | Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delay... | Out of specification results observed in dissolution during long term stability testing. | Class II | Preferred Pharmaceuticals, 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.