Browse Drug Recalls

18,008 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,008 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 18,008 FDA drug recalls.

DateProductReasonClassFirm
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 3, 2022 HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Do... Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... Class I STAQ Pharma, Inc.
Feb 3, 2022 Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose ... Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... Class I STAQ Pharma, Inc.
Jan 28, 2022 HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per... Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed... Class I Esupplementsales, LLC
Jan 28, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles p... Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... Class II AMS Packaging Inc
Jan 28, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle pa... Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... Class II AMS Packaging Inc
Jan 26, 2022 Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automati... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx O... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amnea... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, UL... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged ... Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot Class I AuroMedics Pharma LLC
Jan 26, 2022 HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx onl... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Man... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bott... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packe... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applic... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg,... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tab... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healt... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylam... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lup... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufa... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTR... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby La... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Heal... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufact... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Labo... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsul... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE

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.