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 |
|---|---|---|---|---|
| Aug 3, 2017 | Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... | Failed Impurities/Degradation Specifications: out-of-specification results obtained for individua... | Class III | KVK-Tech, Inc. |
| Aug 2, 2017 | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 3... | Failed Moisture Limits: out of specification test results for water content obtained during stabi... | Class III | Teva Pharmaceuticals USA |
| Jul 25, 2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 po... | Failed Impurities/Degradation Specifications: high out of specification results for related compo... | Class III | Teva Pharmaceuticals USA |
| Jul 19, 2017 | Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Ma... | Failed impurities/degradation specifications: Out of specification for a related compound C. | Class III | AVKARE Inc. |
| Jul 17, 2017 | Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxyci... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Ne... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methox... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net W... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 12, 2017 | Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlor... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 12, 2017 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose ... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 12, 2017 | Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlor... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 12, 2017 | Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL... | CGMP Deviations: Firm failed to control impurity for color change at the API stage. | Class III | Pfizer Inc. |
| Jul 11, 2017 | Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC ... | Failed Impurities/Degradation Specifications: high out of specification results for related impur... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jul 6, 2017 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Onl... | Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-re... | Class III | Hospira Inc., A Pfizer Company |
| Jun 29, 2017 | Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bot... | Failed Impurities/Degradation Specifications: out of specification test results for related comp... | Class III | Teva Pharmaceuticals USA |
| Jun 29, 2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle... | Failed Impurities/Degradation Specifications: out of specification test results for related comp... | Class III | Teva Pharmaceuticals USA |
| Jun 28, 2017 | Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only,... | Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being ... | Class III | Valeant Pharmaceuticals North America LLC |
| 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. |
| Jun 16, 2017 | Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 07... | Cross Contamination With Other Product: Imipramine | Class III | Sandoz Incorporated |
| Jun 12, 2017 | Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor C... | Superpotent Drug: high out-of-specification result for magnesium. | Class III | Sanofi-Aventis U.S. LLC |
| Jun 5, 2017 | Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two pla... | Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the... | Class III | L. Perrigo Company |
| Jun 2, 2017 | G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 071... | Failed impurities/degradation specifications: This product is being recalled due to out of specif... | Class III | G & W Laboratories, Inc. |
| May 30, 2017 | BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Onl... | Failed Moisture Limits: Product tested out-of-specification for moisture content. | Class III | Mckesson Packaging Services |
| 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 24, 2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed b... | Presence of foreign substance: The recall was initiated due to black particles being observed whi... | Class III | Shionogi Inc. |
| 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 18, 2017 | Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple... | Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile resi... | Class III | Lantheus MI Radipharmaceuticals Inc. |
| May 17, 2017 | Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60m... | Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved ... | Class III | VistaPharm, Inc. |
| May 9, 2017 | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Str... | Failed Stability Specifications: Out of Specification results obtained for preservative Methylpar... | Class III | Strides Pharma INC |
| May 9, 2017 | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals ... | Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurit... | Class III | Mylan Pharmaceuticals Inc. |
| May 8, 2017 | HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactur... | Superpotent Drug: above specification for the assay. | Class III | Vintage Pharmaceuticals LLC, DBA Qualitest Phar... |
| May 5, 2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... | PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... | Class III | Ascend Laboratories LLC |
| May 2, 2017 | Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufa... | CGMP Deviations | Class III | Lupin Pharmaceuticals Inc. |
| Apr 27, 2017 | Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: ... | Presence of Foreign Substance: human hair melded into tablet. | Class III | Hetero USA Inc |
| Apr 27, 2017 | Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... | Defective Delivery System: Out of specification for peel force from the release liner specificati... | Class III | Noven Pharmaceuticals, Inc. |
| Apr 26, 2017 | Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 coun... | Subpotent Drug; Clavulanic Acid | Class III | Sandoz Inc |
| Apr 20, 2017 | IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit con... | Product is being recalled due to low pH value. | Class III | Akorn, Inc. |
| Apr 18, 2017 | Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, ... | Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. | Class III | Sun Pharmaceutical Industries, Inc. |
| Apr 17, 2017 | Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pi... | Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel.... | Class III | Fagron, Inc |
| Apr 17, 2017 | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgel... | Subpotent: This product is being recalled due to low out of specification assay results at the 9... | Class III | P & L Development, 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.