Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 8, 2019 | Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL sin... | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... | Class II | Avella of Deer Valley, Inc. Store 38 |
| Feb 7, 2019 | Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Labo... | Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. | Class III | ACP Nimble Buyer, Inc. |
| Feb 6, 2019 | Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottl... | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 6, 2019 | Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) b... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, E... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... | Class III | Advanced Pharma Inc. |
| Feb 6, 2019 | Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje... | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... | Class III | Advanced Pharma Inc. |
| Feb 6, 2019 | Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... | Class III | Advanced Pharma Inc. |
| Feb 6, 2019 | Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 f... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of... | Labeling: Incorrect expiration date. | Class II | Advanced Pharma Inc. |
| Feb 4, 2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl... | Failed Stability Specification: out of specification results for Sodium Perborate | Class II | Akorn Inc |
| Feb 4, 2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos... | CGMP Deviations | Class II | ICU Medical Inc |
| Feb 1, 2019 | Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx... | Presence of Particulate Matter: particulate matter identified as copper salts | Class I | Mylan Institutional Inc |
| Feb 1, 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Man... | Failed Impurities/Degradation Specifications: Out of specification test results in related substa... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 1, 2019 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... | Defective Container: Potential for broken glass in the neck area of the glass bottles. | Class II | Mylan Pharmaceuticals Inc. |
| Jan 31, 2019 | Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx ... | Failed Dissolution Specifications: Out of specification results observed for high dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 30, 2019 | Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles... | Failed Dissolution Specifications: high out of specification results for dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| Jan 29, 2019 | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoun... | Lack of assurance of sterility. | Class II | US Compounding Inc |
| Jan 28, 2019 | Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02)... | Failed Impurities/Degradation Specifications: OOS results observed in any other individual impuri... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 25, 2019 | the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pru... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... | Class I | Natures Rx |
| Jan 25, 2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an... | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ... | Class III | Akorn Inc |
| Jan 24, 2019 | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date an... | Class II | US Compounding Inc |
| Jan 24, 2019 | BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distr... | Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0... | Failed Impurities/Degradation Specifications: Related compound results obtained during routine st... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 18, 2019 | Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huah... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Onl... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 18, 2019 | Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for... | Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected durin... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jan 18, 2019 | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Prinston Pharmaceutical Inc |
| Jan 16, 2019 | NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 ... | Labeling: Label mix-up | Class II | KRS Global Biotechnology, Inc |
| Jan 16, 2019 | Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards,... | Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate S... | Class II | Rx Pak Division of McKesson Corporation |
| Jan 16, 2019 | NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 ... | Labeling: Label mix-up | Class II | KRS Global Biotechnology, Inc |
| Jan 15, 2019 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m... | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Class II | Tris Pharma Inc. |
| Jan 15, 2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Class II | Tris Pharma Inc. |
| Jan 15, 2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Class II | Tris Pharma Inc. |
| Jan 15, 2019 | Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, ... | Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated ou... | Class II | LUPIN SOMERSET |
| Jan 15, 2019 | HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodiu... | Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/5... | Class II | Advanced Pharma Inc. |
| Jan 15, 2019 | Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, M... | Presence of Foreign Substance: Product complaint of black speckles observed on tablets. | Class II | Dr. Reddy's Laboratories, Inc. |
| Jan 11, 2019 | Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufact... | Defective Container; complaints of leakage. | Class III | Oxalis Labs |
| Jan 10, 2019 | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | MAJOR PHARMACEUTICALS |
| Jan 10, 2019 | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 m... | Presence of Particulate Matter: filmy/cloudy particulate observed in vial. | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Jan 9, 2019 | Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lu... | CGMP Deviations; presence of extraneous material in the was observed in area that is between the... | Class II | Lupin Pharmaceuticals Inc. |
| Jan 8, 2019 | 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Hap... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... | Class I | Happy Together, Inc. |
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.