Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx ... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx ... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 9, 2023 | JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-01... | Labeling: Label Mix-up | Class II | Boehringer Ingelheim Pharmaceuticals, 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 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 | 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, 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 | 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 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. |
| 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 |
| 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 | 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 | 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 | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Aci... | 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 | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| 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 | Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... | CGMP Deviations: Potential product carryover. | Class II | Nephron Sc Inc |
| 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 | NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, ... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 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 | 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 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 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 15, 2023 | Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by:... | Failed Impurities/Degradation Specifications | Class II | RISING PHARMACEUTICALS |
| 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 14, 2023 | Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles,... | CGMP Deviations | Class II | Pharmedica USA, LLC |
| Feb 10, 2023 | 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B.... | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... | Class II | B. Braun Medical Inc. |
| Feb 10, 2023 | 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B... | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... | Class II | B. Braun Medical Inc. |
| Feb 9, 2023 | Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by... | Failed Impurities/Degradation Specifications | Class II | L. Perrigo Company |
| Feb 9, 2023 | Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive ... | cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. | Class II | HTO Nevada, Inc. |
| Feb 9, 2023 | allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-... | Failed Impurities/Degradation Specifications | Class II | L. Perrigo Company |
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.