Browse Drug Recalls
17 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17 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 17 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 | 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 |
| Aug 2, 2016 | Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distribu... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Aug 2, 2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 ... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Jul 11, 2016 | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... | Failed Dissolution Specifications | Class II | Actavis Inc |
| Jun 30, 2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufact... | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... | Class II | Actavis Inc |
| Jun 4, 2015 | Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ... | Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro... | Class III | Actavis Inc |
| Feb 12, 2015 | Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx... | Subpotent Drug | Class II | Actavis Inc |
| Feb 12, 2015 | Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx... | Subpotent Drug | Class II | Actavis Inc |
| Aug 25, 2014 | Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only... | Subpotent Drug | Class II | Actavis Inc |
| Aug 25, 2014 | Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only... | Subpotent Drug | Class II | Actavis Inc |
| May 16, 2014 | Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsul... | Subpotent Drug. | Class II | Actavis Inc |
| Dec 9, 2013 | Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (ND... | Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial... | Class II | Actavis Inc |
| Nov 15, 2013 | BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... | Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. | Class III | Actavis Inc |
| Jul 31, 2013 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... | Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above appro... | Class III | Actavis Inc |
| Mar 22, 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx onl... | Failed Tablet/Capsule Specifications: Broken tablets | Class II | Actavis Inc |
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.