Browse Drug Recalls

1,723 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,723 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 1,723 FDA drug recalls — Class I.

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DateProductReasonClassFirm
Sep 17, 2020 NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx O... Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... Class I Acella Pharmaceuticals, LLC
Sep 17, 2020 NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx On... Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... Class I Acella Pharmaceuticals, LLC
Sep 9, 2020 M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7... Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel... Class I MEDEK LLC
Sep 3, 2020 Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99... Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an... Class I CORGIOMED LLC
Sep 1, 2020 Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag st... Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approv... Class I The Protein Shoppe
Aug 25, 2020 WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, ... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levoth... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Le... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, L... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 17, 2020 Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural... Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be cont... Class I Maison Terre, LLC
Aug 17, 2020 Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 17, 2020 Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 14, 2020 SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG2... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Al... Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the la... Class I Volu-Sol, Inc.
Aug 14, 2020 Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Boli... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a)... Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-... Class I Grupo Asimex de Mexico SA de CV
Aug 14, 2020 SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: ... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packag... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 6, 2020 Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kill... Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for e... Class I Incredible Products, SA de CV
Jul 29, 2020 Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Cont... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 27, 2020 HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below ... Class I Broncolin, S.A. de C.V.
Jul 23, 2020 BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 ... Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol con... Class I Real Clean Distribuciones SA de CV
Jul 22, 2020 Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m... Cross Contamination with other products: trace amounts of lidocaine Class I Fresenius Kabi USA, LLC
Jul 21, 2020 STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with s... Superpotent Drug Class I Ferring Pharmaceuticals Inc
Jul 21, 2020 Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap... Superpotent Drug Class I Ferring Pharmaceuticals Inc
Jul 21, 2020 DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only... Superpotent Drug Class I Ferring Pharmaceuticals Inc
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L)... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L)... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) d... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 7, 2020 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jul 7, 2020 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV reg... Class I CareFusion 213, LLC
Jul 7, 2020 Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma... Presence of Particulate Matter Class I Mylan Institutional LLC
Jul 7, 2020 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jul 7, 2020 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV reg... Class I CareFusion 213, LLC
Jul 2, 2020 bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... Chemical Contamination: Product contains methanol. Class I AAA Cosmetica, SA de CV
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
Jun 29, 2020 Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antisepti... Chemical Contamination: Presence of Undeclared Methanol Class I Transliquid Technologies, 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 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 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 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

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.