Allergan PLC

Complete recall history across all FDA and CPSC categories — 23 total recalls

Allergan PLC appears in recall records across 2 categories. 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 (2)

FDA drug safety enforcement actions by Allergan PLC

Date Product Reason Class
Jul 6, 2020 Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distr... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III
Jul 6, 2020 Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III

Device Recalls (21)

FDA medical device enforcement actions by Allergan PLC

Date Product Reason Class
Dec 29, 2020 REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile Missing Instruction For Use insert. Class II
Nov 6, 2019 NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, ... The firm has became aware that 2D barcodes on breast implants and sizers may ... Class III
Nov 6, 2019 Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles an... The firm has became aware that 2D barcodes on breast implants and sizers may ... Class III
Nov 6, 2019 Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, St... The firm has became aware that 2D barcodes on breast implants and sizers may ... Class III
Nov 6, 2019 Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: ... The firm has became aware that 2D barcodes on breast implants and sizers may ... Class III
Oct 30, 2019 XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ;... Residual polishing compounds, that are used in the needle sleeve manufacturin... Class II
Jul 24, 2019 RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usag... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Impl... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander a... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Proj... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Pro... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intende... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), ... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioD... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styl... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Heigh... The action was initiated following notification by the U.S. FDA of their rece... Class I
Jul 24, 2019 Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, St... The action was initiated following notification by the U.S. FDA of their rece... Class I

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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