Browse Drug Recalls
18 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18 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 18 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 22, 2023 | Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx onl... | Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two ... | Class III | West-Ward Columbus Inc |
| Jul 22, 2020 | Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr.... | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. | Class III | West-Ward Columbus Inc |
| May 13, 2020 | Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. b... | Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degra... | Class III | West-Ward Columbus Inc |
| May 13, 2020 | Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... | Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... | Class II | West-Ward Columbus Inc |
| Jul 30, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do... | Failed Dissolution Specifications | Class II | MAJOR PHARMACEUTICALS |
| Jul 24, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufact... | Failed Dissolution Specifications: | Class II | West-Ward Columbus Inc |
| Jul 24, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufac... | Failed Dissolution Specifications: | Class II | West-Ward Columbus Inc |
| Nov 6, 2017 | Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Via... | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 6, 2017 | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-... | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone... | Class III | West-Ward Pharmaceuticals Corp. |
| 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. |
| 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 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. |
| Oct 3, 2016 | PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-War... | Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. | Class II | West-Ward Pharmaceutical |
| 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. |
| Aug 18, 2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re... | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 10, 2015 | Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... | Labeling: Not elsewhere classified. NDC number is incorrect on the container. | Class III | Northwind Pharmaceuticals LLC |
| Jun 4, 2013 | VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tabl... | Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification resu... | Class II | West-Ward Pharmaceutical Corp. |
| Dec 7, 2012 | Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bo... | Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tab... | Class II | West-ward Pharmaceutical 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.