Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 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 3,394 FDA drug recalls.

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DateProductReasonClassFirm
Sep 23, 2024 Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan in... CGMP deviations Class II Advanced Accelerator Applications USA, Inc.
Sep 18, 2024 EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz... CGMP deviations Class II EnviroServe Chemicals Inc.
Sep 11, 2024 Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Singl... cGMP Deviations: Temperature excursion Class II Mckesson Medical-Surgical Inc. Corporate Office
Aug 5, 2024 HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) ... CGMP Deviations: sterile water not used for production Class II Zeco LLC
Aug 5, 2024 Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a)... CGMP Deviations: sterile water not used for production Class II Zeco LLC
Jul 22, 2024 Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Jul 2, 2024 Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotox... CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltere... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 26, 2024 Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML... CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. Class II Equibal Inc
Jun 26, 2024 Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystallin... CGMP Deviations and Presence of Particulate Matter: Glass Class II Medisca Inc.
Jun 26, 2024 Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count... CGMP Deviations: Out of specification for dissolution Class II RemedyRepack Inc.
Jun 20, 2024 Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) pa... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as ... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Package... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) P... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packag... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UP... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL ... CGMP deviations Class II Little Moon Essentials LLC
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
May 28, 2024 Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz.... cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel e... Class II Denison Pharmaceuticals, LLC
May 24, 2024 suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple S... CGMP Deviations Class II SYNCHRONICITY SPA INC, DBA SUNTE
May 17, 2024 Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mf... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, 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 13, 2024 Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-... CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... Class II Glenmark Pharmaceuticals Inc., USA
May 13, 2024 Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit... CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... Class II Glenmark Pharmaceuticals Inc., USA
May 10, 2024 Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufa... CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... Class II Glenmark Pharmaceuticals Inc., USA
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 Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufact... CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... Class II Glenmark Pharmaceuticals Inc., USA
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 23, 2024 minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count... CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... Class II EPI Health, LLC
Apr 23, 2024 Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, N... CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... Class II EPI Health, LLC
Apr 23, 2024 minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count... CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... Class II EPI Health, LLC
Apr 12, 2024 Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jar... cGMP Deviations Class II Dercher Enterprises, Inc., DBA Gordon Laboratories
Mar 29, 2024 Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents:... CGMP Deviations Class II HONEYWELL INC
Mar 27, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... CGMP Deviations Class II NATCO Pharma Limited
Mar 21, 2024 VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9... cGMP Diviations Class II Apothecus Pharmaceutical Corp.
Mar 12, 2024 Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 RE... CGMP Deviations Class II Eli Lilly & Company
Mar 4, 2024 Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2024 Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Feb 19, 2024 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic,... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Clean... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scen... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antis... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Clean... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
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 12, 2024 Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs... CGMP Deviations: Out of specification for residual solvents. Class II Micro Labs Limited
Feb 12, 2024 CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1... CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was... Class II MCKESSON CORPORATION

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.