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.

DateProductReasonClassFirm
Jul 2, 2020 Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finast... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Libe... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-0... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle,... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... CGMP Deviations Class II AAA Cosmetica, SA de CV
Jul 2, 2020 Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 1, 2020 Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), F... Microbial contamination of non-sterile products: positive microbial contamination in product. Class I Spartan Chemical Co Inc
Jul 1, 2020 Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% to... CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test ... Class II Preferred Pharmaceuticals, Inc.
Jun 29, 2020 Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antisepti... Chemical Contamination: Presence of Undeclared Methanol Class I Transliquid Technologies, LLC
Jun 29, 2020 Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutane... Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber ... Class II EMD Serono, Inc.
Jun 29, 2020 Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... Class II RemedyRepack Inc.
Jun 25, 2020 Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr... CGMP Deviations: Product was found to be below the label claim for ethanol content and the presen... Class II POLARIZED LLC
Jun 24, 2020 Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX O... Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia... Class I Medichem S.A.
Jun 23, 2020 ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
Jun 23, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl... Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... Class III VistaPharm, Inc.
Jun 23, 2020 All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%,... Chemical Contamination: Product contains undeclared methanol. Class I Itech 361 LLC
Jun 23, 2020 Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bott... cGMP deviations: one lot of the product was distributed to US Markets despite being rejected duri... Class III Biogen MA Inc.
Jun 23, 2020 ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
Jun 23, 2020 Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only,... Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... Class III VistaPharm, Inc.
Jun 23, 2020 BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) an... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
Jun 22, 2020 Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr... Chemical Contamination: Product contains undeclared methanol. Class I UVT INC
Jun 18, 2020 BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 F... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Vanilla, 1500MG CBD,1 FL. OZ (30ML) bottles, D... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottl... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spe... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Herbzeedy, Hemp Oil Full Spectrum, Natural, 500 MG CBD, 1 FL OZ (30 ML) bottl... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops Hemp Oil Extract, Spearmint, 1 FL. OZ (30ML) bottles, 300MG CBD, ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles,... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Di... Chemical Contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops Hemp Oil Extract, Vanilla, 1 FL. OZ (30ML) bottles, 300MG CBD, Di... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bo... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 SP, hemp oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by:... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Made by Hemp 1000MG Hemp Extract, Strawberry Creme, 1 OZ (30 ML) bottles, Dis... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 A Clean Choice CBD, Hemp Oil Extract Tincture, Strawberry Creme, 1000mg, 1 fl... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 A Clean Choice CBD, Hemp Oil Extract Tincture, Sweet Mint, 500mg, 1 fl oz (30... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES

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.