Browse Drug Recalls
2,012 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,012 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 2,012 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 17, 2021 | Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Pres... | Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rath... | Class III | Edge Pharma, LLC |
| Feb 10, 2021 | Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te... | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... | Class II | Teva Pharmaceuticals USA |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut... | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 m... | Class I | Apotex Corp. |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati... | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 12... | Class I | Apotex Corp. |
| Feb 1, 2021 | Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed... | Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled a... | Class II | Kimberly-Clark Corporation |
| Jan 28, 2021 | Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V... | Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo... | Class III | Accord Healthcare, Inc. |
| Jan 27, 2021 | Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dos... | Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain t... | Class I | Meitheal Pharmaceuticals Inc |
| Jan 27, 2021 | Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636... | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact... | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Jan 27, 2021 | Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma... | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact... | Class II | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Jan 15, 2021 | Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distribute... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class III | Calvin Scott & Company, Inc. |
| Jan 15, 2021 | Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by C... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class I | Calvin Scott & Company, Inc. |
| Jan 11, 2021 | Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL... | Incorrect Labeling: Incorrect lot number on secondary packaging | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 6, 2021 | Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F... | Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place... | Class II | DLC Laboratories, Inc |
| Dec 30, 2020 | Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) S... | Labeling: Missing instructions for use insert | Class II | Allergan, PLC. |
| Dec 23, 2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Ma... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | Shane Erickson Inc |
| Dec 23, 2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Mad... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | Shane Erickson Inc |
| Dec 23, 2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottl... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | Shane Erickson Inc |
| Dec 22, 2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Edge Pharma, LLC |
| Dec 17, 2020 | Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(bar... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class II | SCA Pharmaceuticals |
| Dec 17, 2020 | ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (4... | Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast | Class I | NDAL Mfg Inc. |
| Dec 16, 2020 | Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ... | Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in... | Class III | US Compounding Inc |
| Nov 25, 2020 | Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit... | Labelling: Missing label. | Class III | US Compounding Inc |
| Nov 20, 2020 | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p... | Labeling: Label mix-up | Class III | Novocol Pharmaceutical of Canada, Inc. |
| Oct 22, 2020 | Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL ... | Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. | Class III | Aurobindo Pharma USA Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bo... | Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap. | Class II | Jarrow Formulas Inc |
| Oct 1, 2020 | Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL),... | Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleadin... | Class I | ASHTEL STUDIOS, INC. |
| 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 17, 2020 | Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologic... | Labeling: Product Contains Undeclared API; Incorrect formulation | Class III | Grato Holdings, Inc. |
| Sep 11, 2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactu... | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... | Class II | Genesis Partnership Company SA |
| Sep 11, 2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manuf... | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... | Class II | Genesis Partnership Company SA |
| 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 9, 2020 | Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces ... | Labeling: Incorrect or Missing Package Insert: The package insert included in the finished produc... | Class III | P & L Developments, 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 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 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 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 | 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 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 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 10, 2020 | Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannet... | Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contai... | Class II | Lannett Company, Inc. |
| Aug 7, 2020 | Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in ... | Labeling Not Elsewhere Classified: Product labeled to contain methanol | Class II | Open Book Extracts |
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.