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 |
|---|---|---|---|---|
| Sep 9, 2016 | Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankles... | Microbial Contamination of Non-Sterile Product | Class II | Cadila Pharmaceuticals Limited |
| Sep 2, 2016 | Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Sep 2, 2016 | Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Sep 2, 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pac... | Defective Delivery System; reports of damaged product that may alter the predicted release of sco... | Class II | Sandoz Inc |
| Aug 24, 2016 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 ... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 6675... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 24, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Class II | Amerisource Health Services |
| Aug 22, 2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 22, 2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 22, 2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 15, 2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be ... | Discoloration: Firm received complaints of product discoloration and particulates. | Class II | Hospira Inc. |
| Aug 10, 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) ... | Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product st... | Class II | Allergy Laboratories, Inc. |
| Aug 8, 2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. ... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bay... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg i... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by:... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 3, 2016 | Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets pe... | Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of on... | Class II | Aurobindo Pharma USA Inc |
| Aug 3, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules p... | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Class II | Golden State Medical Supply Inc. |
| Aug 3, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per ... | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Class II | Golden State Medical Supply Inc. |
| Aug 1, 2016 | Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension,... | Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate /... | Class II | Isomeric Pharmacy Solution, LLC |
| Aug 1, 2016 | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical M... | Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. | Class II | Spectrum Laboratory Products, Inc. |
| Jul 29, 2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufacture... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured ... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 28, 2016 | C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pha... | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... | Class II | Colonia Care Pharmacy |
| Jul 28, 2016 | C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy,... | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... | Class II | Colonia Care Pharmacy |
| Jul 26, 2016 | Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg,... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesbur... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compound... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostagland... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 3... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hatt... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
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.