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 |
|---|---|---|---|---|
| Jul 17, 2018 | Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 17, 2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Jul 17, 2018 | Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (... | CGMP Deviations | Class II | Longbow First Aid Products Manufactory |
| Jul 17, 2018 | Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (ND... | CGMP Deviations | Class II | Longbow First Aid Products Manufactory |
| Jul 17, 2018 | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Jul 17, 2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochloroth... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 17, 2018 | Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 17, 2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochloroth... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, U... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Ma... | API material used in the manufacturing of the product did not receive regulatory approval prior t... | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bo... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, U... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Ta... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Ta... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tab... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tabl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tabl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only M... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only M... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 12, 2018 | Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distr... | Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. | Class II | Sun Pharmaceutical Industries, Inc. |
| Jul 5, 2018 | Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection,... | Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. | Class II | Sanofi-Aventis U.S. LLC |
| Jul 5, 2018 | Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, ... | Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) t... | Class II | Teva Pharmaceuticals USA |
| Jul 5, 2018 | alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9... | Incorrect Product Formulation: wrong sunscreen product in the package. | Class II | The Hain Celestial Group, Inc. - Worldwide HQ |
| Jul 3, 2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... | CGMP Deviations: The manufacturer of this product recalled because they were not manufactured und... | Class II | Medgyn Products, Inc. |
| Jul 3, 2018 | Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL),... | CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a... | Class II | Medi-Fare Drug and Home Health Center |
| Jul 3, 2018 | Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a ... | Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, ... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jun 29, 2018 | Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... | Subpotent Drug: Stability data does not support the current expiration dating of 55 days after co... | Class II | SCA Pharmaceuticals |
| Jun 28, 2018 | Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per... | Microbial Contamination of Sterile Products: Product associated with reports of adverse events in... | Class II | PFIZER |
| Jun 28, 2018 | Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufac... | Subpotent Drug and Failed Content Uniformity. | Class II | LUPIN SOMERSET |
| Jun 25, 2018 | Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Wate... | Lack of Processing Controls: products produced in a manner that calls into question the sterility... | Class II | La Vita Compounding Pharmacy, LLC |
| Jun 25, 2018 | Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)... | Lack of Processing Controls: products produced in a manner that calls into question the sterility... | Class II | La Vita Compounding Pharmacy, LLC |
| Jun 25, 2018 | Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water)... | Lack of Processing Controls: products produced in a manner that calls into question the sterility... | Class II | La Vita Compounding Pharmacy, LLC |
| Jun 22, 2018 | eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hy... | Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity | Class II | Eb5 Corporation |
| Jun 22, 2018 | Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by ... | CGMP Deviations | Class II | Akorn, Inc. |
| Jun 20, 2018 | fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL ... | Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated ... | Class II | Advanced Pharma Inc. |
| Jun 14, 2018 | Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chlor... | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... | Class II | SCA Pharmaceuticals, LLC |
| Jun 14, 2018 | Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... | Class II | SCA Pharmaceuticals, LLC |
| Jun 14, 2018 | Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA P... | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... | Class II | SCA Pharmaceuticals, LLC |
| Jun 14, 2018 | Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... | Class II | SCA Pharmaceuticals, LLC |
| Jun 14, 2018 | Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume... | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... | Class II | SCA Pharmaceuticals, LLC |
| Jun 14, 2018 | Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA P... | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... | Class II | SCA Pharmaceuticals, LLC |
| Jun 14, 2018 | Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... | Class II | SCA Pharmaceuticals, 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.