Browse Drug Recalls

1,091 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,091 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 1,091 FDA drug recalls in CA.

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DateProductReasonClassFirm
Jul 17, 2023 lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 79... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syring... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL sy... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total V... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx onl... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc.... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syri... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixtur... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixt... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Ce... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syring... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jun 26, 2023 Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 687... Failed Stability Specifications Class II Preferred Pharmaceuticals, Inc.
Jun 23, 2023 PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only... Failed Stability Specifications Class III Vivus, Inc.
Jun 13, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 13, 2023 Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
May 25, 2023 Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx onl... Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. Class II Golden State Medical Supply Inc.
May 9, 2023 Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dext... Subpotent: Low anti-factor IIa Potency. Class II B. Braun Medical Inc
Apr 26, 2023 NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power C... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... Class I Gadget Island, Inc
Apr 26, 2023 Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by B... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... Class I Gadget Island, Inc
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.

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.