Actavis Inc

Complete recall history across all FDA and CPSC categories — 17 total recalls

Actavis Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (17)

FDA drug safety enforcement actions by Actavis Inc

Date Product Reason Class
Feb 7, 2017 Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... Failed Impurities/ Degradation Specifications: OOS for related compound (levo... Class III
Jan 30, 2017 Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Above out of specification for dissolution... Class II
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... Class III
Aug 2, 2016 Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distribu... Failed Impurities/Degradation Specifications: Out of specification (OOS) resu... Class III
Aug 2, 2016 Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 ... Failed Impurities/Degradation Specifications: Out of specification (OOS) resu... Class III
Jul 11, 2016 Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... Failed Dissolution Specifications Class II
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 dis... Class II
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 beca... Class III
Feb 12, 2015 Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx... Subpotent Drug Class II
Feb 12, 2015 Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx... Subpotent Drug Class II
Aug 25, 2014 Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only... Subpotent Drug Class II
Aug 25, 2014 Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only... Subpotent Drug Class II
May 16, 2014 Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsul... Subpotent Drug. Class II
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/... Class II
Nov 15, 2013 BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... Failed Dissolution Specifications: Failed stability testing for dissolution t... Class III
Jul 31, 2013 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... Failed Dissolution Specifications: Dissolution test results at 8 hour time-po... Class III
Mar 22, 2013 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx onl... Failed Tablet/Capsule Specifications: Broken tablets Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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