Browse Drug Recalls
1,720 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,720 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 1,720 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 15, 2017 | Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 13, 2017 | Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruh... | Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... | Class III | L. Perrigo Company |
| Feb 13, 2017 | Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Y... | Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... | Class III | L. Perrigo Company |
| Feb 13, 2017 | PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TO... | Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. | Class III | Colgate Palmolive Co |
| Feb 7, 2017 | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... | Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... | Class III | Actavis Inc |
| Feb 2, 2017 | Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Cover... | Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Ca... | Class III | Sage Products Inc |
| Jan 30, 2017 | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 bli... | Chemical Contamination: out of specification results for impurities were found to be the result o... | Class III | Mylan Pharmaceuticals Inc. |
| Jan 30, 2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and ... | Chemical Contamination: out of specification results for impurities were found to be the result o... | Class III | Mylan Pharmaceuticals Inc. |
| Jan 27, 2017 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 ... | Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of... | Class III | Pharmedium Services, LLC |
| Jan 16, 2017 | Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, ... | Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-... | Class III | LEO PHARMA INC |
| Jan 16, 2017 | DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for:... | Failed Impurities/ Degradation Specifications | Class III | Vintage Pharmaceuticals LLC dba Qualitest Pharm... |
| Jan 12, 2017 | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vial... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Actavis Inc |
| Jan 7, 2017 | Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for... | Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue ... | Class III | Hetero USA Inc |
| Jan 5, 2017 | Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, ... | Subpotent | Class III | InnovaGel |
| Jan 5, 2017 | Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swi... | Subpotent | Class III | InnovaGel |
| Jan 4, 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... | Supotent: Out of Specification result for assay test during routine stability testing. | Class III | Mckesson Packaging Services |
| Dec 29, 2016 | Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : ... | Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of p... | Class III | Hetero Drugs Ltd. - Unit 1 |
| Dec 27, 2016 | Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by ... | Superpotent Drug; out of specification results for assay (manufacturer) | Class III | The Harvard Drug Group |
| Dec 22, 2016 | TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for:... | Failed Stability Specifications | Class III | Vintage Pharmaceuticals LLC, DBA Qualitest Phar... |
| Dec 20, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND... | Failed Dissolution Specifications; 18 month stability time point | Class III | Sun Pharmaceutical Industries, Inc. |
| Dec 20, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ... | Failed Dissolution Specifications; 18 month stability time point | Class III | Sun Pharmaceutical Industries, Inc. |
| Dec 19, 2016 | Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex... | Superpotent Drug: Product may not meet specifications throughout shelf life. | Class III | Apotex Inc. |
| Dec 16, 2016 | Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only,... | Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. | Class III | Aurobindo Pharma USA Inc |
| Dec 14, 2016 | Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spra... | Defective Delivery System: out of specification result for droplet size distribution at the d90 m... | Class III | Roxane Laboratories, Inc. |
| Dec 13, 2016 | Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC ... | Subpotent Drug: out of specification results for assay test. | Class III | Sandoz Inc |
| Dec 12, 2016 | Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Di... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Min... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing ... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 7, 2016 | Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10... | Subpotent Drug: Out of specification result for pramoxine hydrochloride | Class III | Novum Pharma, LLC |
| Dec 6, 2016 | INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only,... | Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed vari... | Class III | Cipher Pharmaceuticals US LLC |
| Dec 2, 2016 | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, R... | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 25... | Class III | Shire PLC |
| Dec 2, 2016 | Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, pa... | Subpotent Drug | Class III | Ecolab, Inc. |
| Dec 1, 2016 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... | Failed Dissolution Specifications | Class III | Teva Pharmaceuticals USA |
| Nov 22, 2016 | PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop... | Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. | Class III | Pfizer Inc. |
| Nov 22, 2016 | Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed... | Labeling: Label Mix Up- Incorrect back label applied to the product. | Class III | Les Emballages Knowlton Inc. |
| Nov 17, 2016 | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5... | Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 8, 2016 | Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.... | Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and ... | Class III | Care-Tech Laboratories, Inc. |
| Nov 4, 2016 | Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted)... | Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the stren... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 3, 2016 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 03... | Failed Impurities/Degradation Specifications: OOS results for known compound. | Class III | Mylan Pharmaceuticals Inc. |
| Nov 2, 2016 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 3... | Failed Dissolution Specifications; 6 month time point | Class III | Zydus Pharmaceuticals USA Inc |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | Class III | Teva Pharmaceuticals USA |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | Class III | Teva Pharmaceuticals USA |
| Oct 28, 2016 | KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP,... | Failed Stability Specifications: Low Out of Specification results for alcohol content. | Class III | Sun Pharmaceutical Industries, Inc. |
| Oct 27, 2016 | Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-co... | Failed Dissolution Specifications: The firm was notified that there was a dissolution out of spec... | Class III | Amerisource Health Services |
| Oct 20, 2016 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx on... | Labeling: Label error on declared strength. Package Insert -Error in the Description section of t... | Class III | CutisPharma, Inc. |
| Oct 20, 2016 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx ... | Labeling: Label error on declared strength. Package Insert -Error in the Description section of t... | Class III | CutisPharma, Inc. |
| Oct 19, 2016 | Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM ... | Labeling: Missing Label | Class III | Sandoz Inc |
| Oct 19, 2016 | Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-coun... | Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be a... | Class III | Janssen Ortho L.L.C. |
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.