Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 9, 2024 | Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... | CGMP Deviations: potential presence of Burkholderia cepacia complex | Class II | Apotex Corp. |
| Feb 7, 2024 | Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 7, 2024 | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 7, 2024 | Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Sy... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 6, 2024 | Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP uni... | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... | Class II | Mallinckrodt Hospital Products Inc. |
| Feb 6, 2024 | Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only... | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... | Class II | Mallinckrodt Hospital Products Inc. |
| Feb 1, 2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactur... | CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on ... | Class II | NATCO Pharma Limited |
| Jan 25, 2024 | Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat... | CGMP Deviations | Class II | Alpha Aromatics |
| Jan 25, 2024 | Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... | CGMP Deviations | Class II | Amerisource Health Services LLC |
| Jan 19, 2024 | Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS | CGMP Deviations | Class II | OMEZA LLC |
| Jan 19, 2024 | Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials | CGMP Deviations | Class II | OMEZA LLC |
| Jan 19, 2024 | Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
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.