Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 6, 2024 | Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distribut... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... | Class I | Today The World |
| Feb 6, 2024 | SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distrib... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Today The World |
| 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 6, 2024 | Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Today The World |
| Feb 5, 2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, D... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Super Chill Products |
| Feb 5, 2024 | Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bo... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 5, 2024 | Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec... | Labeling: Incorrect or Missing Package Insert | Class II | Lupin Pharmaceuticals Inc. |
| Feb 2, 2024 | Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This pac... | Subpotent Drug: Out of specification for assay | Class II | Bausch Health Companies, Inc. |
| Feb 1, 2024 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged... | Class III | Amerisource Health Services LLC |
| Feb 1, 2024 | To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing ... | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Class I | Integrity Products |
| Feb 1, 2024 | RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a ... | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Class I | Integrity Products |
| Feb 1, 2024 | TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... | Chemical Contamination; presence of benzene. | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| 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 30, 2024 | Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrol... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Package... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| 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 25, 2024 | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 25, 2024 | Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic reg... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 25, 2024 | Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat... | CGMP Deviations | Class II | Alpha Aromatics |
| Jan 23, 2024 | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... | Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ... | Class II | Baxter Healthcare Corporation |
| Jan 22, 2024 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio... | Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon... | Class II | IntegraDose Compounding Services 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 |
| Jan 19, 2024 | Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials | CGMP Deviations | Class II | OMEZA LLC |
| Jan 19, 2024 | Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco 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 18, 2024 | Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 17, 2024 | Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Pack... | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouc... | Class II | Henry Schein Inc. and Glove Club HSI Gloves Inc. |
| Jan 16, 2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of... | Failed Impurities/Degradation Specification: Out of specification for organic impurities | Class II | Ascend Laboratories, LLC |
| Jan 16, 2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, 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.