Browse Drug Recalls
412 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 412 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 412 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 30, 2018 | Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,... | Failed Dissolution Specifications | Class II | AVKARE Inc. |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, Inc. |
| Jan 3, 2018 | Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... | Failed Dissolution Specifications: Low out of specification results for dissolution during annual... | Class II | AVKARE Inc. |
| Nov 21, 2017 | Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Ma... | Failed Dissolution Specification | Class III | Lupin Pharmaceuticals Inc. |
| Nov 9, 2017 | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distrib... | Failed Dissolution Specifications. | Class II | Mayne Pharma Inc |
| Oct 25, 2017 | Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-co... | Failed dissolution specifications; all lots within expiry are being recalled due to out of specif... | Class II | Teva Pharmaceuticals USA |
| Oct 17, 2017 | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,... | Failed Dissolution Specifications: Low out of specification results for dissolution. | Class III | Teva Pharmaceuticals USA |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Jun 22, 2017 | Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, M... | Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 mon... | Class III | Lupin Pharmaceuticals Inc. |
| May 31, 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... | Class I | Teva Pharmaceuticals |
| May 24, 2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distri... | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Class III | Shionogi Inc. |
| May 24, 2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man... | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Class III | Shionogi Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 10, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle ... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals USA Inc |
| May 10, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx ... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals USA Inc |
| May 10, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC ... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals USA Inc |
| Mar 15, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... | Failed Dissolution Specifications; 9 month long term stability | Class II | Zydus Pharmaceuticals USA Inc |
| Mar 13, 2017 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 m... | Failed Dissolution Specifications | Class II | Akorn Inc |
| Mar 7, 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer Inc |
| Mar 7, 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer Inc |
| Mar 7, 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer Inc |
| Feb 17, 2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... | Failed Dissolution Specifications: low out of specification dissolution results found during stab... | Class III | Teva Pharmaceuticals USA |
| 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 15, 2017 | Zenatane (isotretinoin) capsules, 40 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 15, 2017 | Zenatane (isotretinoin) capsules, 30 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 15, 2017 | Zenatane (isotretinoin) capsules, 10 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 10, 2017 | Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx o... | Failed Dissolution Specifications | Class II | Sandoz Inc |
| Feb 7, 2017 | Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsi... | Failed Dissolution Specifications | Class II | RemedyRepack Inc. |
| Feb 3, 2017 | GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21... | Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... | Class II | Amerisource Health Services |
| Jan 30, 2017 | Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa... | Failed Dissolution Specifications. Above out of specification for dissolution rate observed at th... | Class II | Actavis Inc |
| Jan 12, 2017 | Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottl... | Failed Dissolution Specifications | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 5, 2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jan 5, 2017 | Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Dec 28, 2016 | Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 28, 2016 | Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 28, 2016 | Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 28, 2016 | Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 22, 2016 | Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactu... | Failed dissolution specification: recalled due to an out of specification dissolution result of 4... | Class II | Sandoz Incorporated |
| 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 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 12, 2016 | Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals LLC |
| 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 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 |
| 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 3, 2016 | Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War... | Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu... | Class II | West-Ward Pharmaceuticals Corp. |
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.