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.

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Date	Product	Reason	Class	Firm
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.
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

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.