Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Feb 16, 2022 Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packag... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 16, 2022 Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), p... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 15, 2022 Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ... cGMP deviations Class II Macleods Pharma Usa Inc
Feb 15, 2022 Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 14, 2022 Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx ... Subpotent drug Class III BayCare Integrated Service Center, LLC /dba Bay...
Feb 11, 2022 HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only... Non-sterility; bacterial contamination identified as Paenibacillus lautus. Class I Revive Rx LLC dba Revive Rx Pharmacy
Feb 10, 2022 RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton,... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... Class I Positive Health
Feb 9, 2022 Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE ... Failed Impurities/Degradation Specifications: Out of specification results for related substances. Class II Lannett Company, Inc.
Feb 9, 2022 Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Cap... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... Class I Walmart Stores
Feb 8, 2022 MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLD... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 8, 2022 THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... Class I Your Favorite Shop
Feb 8, 2022 RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tad... Class I Celebrate Today
Feb 8, 2022 MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 7, 2022 Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: ... Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubrican... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Feb 7, 2022 Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx ... Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufa... Class II RISING PHARMACEUTICALS
Feb 7, 2022 Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by:... Labeling - product contains undeclared ethyl alcohol Class II Tsm Brands LLC
Feb 7, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by:... Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Relat... Class II Teligent Pharma, Inc.
Feb 7, 2022 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 M... Labeling - product contains undeclared ethyl alcohol Class II Tsm Brands LLC
Feb 4, 2022 MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters pa... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingr... Class I Junp Hydration LLC
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton togethe... Non-sterility Class I CooperSurgical, Inc
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 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 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 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 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 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 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 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 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 Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... 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 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 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
Jan 26, 2022 Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per carton... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, I... 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 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 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 Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II ULTRAtab Laboratories, 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.