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
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.
Mar 24, 2022	Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bot...	CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te...	Class II	Preferred Pharmaceuticals, Inc.
Mar 24, 2022	Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Pre...	CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te...	Class II	Preferred Pharmaceuticals, Inc.
Mar 23, 2022	Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx O...	CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te...	Class II	Preferred Pharmaceuticals, Inc.
Mar 21, 2022	SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled ...	Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr...	Class I	Adamis Pharmaceuticals Corporation
Mar 21, 2022	SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled...	Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr...	Class I	Adamis Pharmaceuticals Corporation
Mar 16, 2022	Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufact...	CGMP Deviations	Class II	Golden State Medical Supply Inc.
Mar 16, 2022	Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactu...	CGMP Deviations	Class II	Golden State Medical Supply Inc.
Mar 16, 2022	Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufact...	CGMP Deviations	Class II	Golden State Medical Supply Inc.
Mar 16, 2022	Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufac...	CGMP Deviations	Class II	Golden State Medical Supply Inc.
Mar 14, 2022	PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a)...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022	PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vial...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022	PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials ...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 14, 2022	TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Sin...	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ...	Class II	Vitae Enim Vitae Scientific, Inc.
Mar 2, 2022	Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR...	CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ...	Class II	Golden State Medical Supply Inc.
Feb 22, 2022	Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b...	CGMP deviations	Class II	Preferred Pharmaceuticals, Inc.
Jan 25, 2022	REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transfo...	Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated...	Class I	Blaine Labs Inc
Dec 3, 2021	Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M...	Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of...	Class I	Gilead Sciences, Inc.
Nov 29, 2021	Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx ...	Defective container: Out of specification for container integrity leading to bottles leaking.	Class II	Preferred Pharmaceuticals, Inc.
Oct 26, 2021	artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ...	Chemical Contamination: presence of benzene, acetaldehyde, and acetal.	Class I	VIRGIN SCENT INC
Oct 26, 2021	artnaturals Hand Sanitizer	CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t...	Class II	VIRGIN SCENT INC
Oct 26, 2021	artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ...	CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t...	Class II	VIRGIN SCENT INC
Oct 14, 2021	Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, M...	Failed Excipient Specification; product manufactured using an excipient found to be OOS for condu...	Class II	Golden State Medical Supply Inc.
Oct 14, 2021	Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets,...	Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us...	Class II	Golden State Medical Supply Inc.
Oct 12, 2021	Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60...	Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua...	Class I	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021	Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC...	Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ...	Class III	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021	Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:...	Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ...	Class III	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 21, 2021	Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chl...	CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or ...	Class II	Sanitor Corporation
Aug 2, 2021	365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN...	Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar...	Class I	Je Dois Lavoir LLC
Jul 30, 2021	FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, R...	Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmen...	Class II	Custopharm, Inc.
Jul 14, 2021	Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4...	Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.	Class I	Qikmoov LLC
Jun 22, 2021	QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, M...	Subpotent	Class II	HOYU(US) LOGISTICS INC
Jun 9, 2021	Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For...	Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content we...	Class II	Genentech Inc
May 11, 2021	Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beau...	Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ing...	Class II	DASH XCLUSIVE
Apr 28, 2021	Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 ...	CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily In...	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.