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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2023 | Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured... | Failed Content Uniformity Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 8, 2023 | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed ... | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry... | Class III | Pfizer Inc. |
| Mar 2, 2023 | Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 5199... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 5... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 519... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL correspon... | Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification result... | Class II | Endo Pharmaceuticals, Inc. |
| Mar 1, 2023 | Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dext... | Subpotent Drug: low Anti-Factor IIa potency. | Class II | B. Braun Medical Inc |
| Mar 1, 2023 | Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL... | Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartr... | Class II | Apotex Corp. |
| Feb 28, 2023 | Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose ... | Labeling: Not elsewhere classified | Class II | Sagent Pharmaceuticals Inc |
| Feb 24, 2023 | Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camp... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed b... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid o... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (20... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed d... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Feb 24, 2023 | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Aci... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83... | Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. | Class I | Global Pharma Healthcare Private Limited |
| Feb 24, 2023 | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) p... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentratio... | Subpotent Drug | Class III | SCA Pharmaceuticals |
| Feb 23, 2023 | Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op... | Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo... | Class II | Teva Pharmaceuticals USA Inc |
| Feb 23, 2023 | NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid D... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx ... | Packaging defect: observed packaging defect, blister packaging inadequately sealed. | Class II | The Harvard Drug Group |
| Feb 23, 2023 | NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), ... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, ... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% A... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... | CGMP Deviations: Potential product carryover. | Class II | Nephron Sc Inc |
| Feb 22, 2023 | Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 22, 2023 | Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | Teva Pharmaceuticals USA Inc |
| Feb 22, 2023 | Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 m... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 22, 2023 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 22, 2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 m... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 22, 2023 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 22, 2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 22, 2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 22, 2023 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Feb 21, 2023 | Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 21, 2023 | Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 21, 2023 | Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f... | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Stan... | Class III | Padagis US LLC |
| Feb 21, 2023 | Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiter... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 21, 2023 | Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV ... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 17, 2023 | Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured... | Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800... | Class III | Sciegen Pharmaceuticals Inc |
| Feb 17, 2023 | DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Akron Pharma, Inc. |
| Feb 15, 2023 | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL... | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Class II | Azurity Pharmaceuticals, Inc. |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 15, 2023 | Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by:... | Failed Impurities/Degradation Specifications | Class II | RISING PHARMACEUTICALS |
| Feb 14, 2023 | Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-S... | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and ace... | Class I | Nanomaterials Discovery Corporation |
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.