Allergan Recalls
33 recalls on record · July 15, 2015 to February 10, 2021 · Drugs, Medical Devices
Recalls by year
15
18
19
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 10, 2021Medical DevicesFDA
Allergan PLC recalls REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Hazard: Missing Instruction For Use insert.
January 27, 2021DrugsFDA
Allergan, PLC. recalls Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie
Hazard: Labeling: Missing instructions for use insert
August 5, 2020DrugsFDA
Allergan PLC recalls Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Ac
Hazard: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
August 5, 2020DrugsFDA
Allergan PLC recalls Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, C
Hazard: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
December 25, 2019Medical DevicesFDA
Allergan PLC recalls NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (resp
Hazard: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
December 25, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513
Hazard: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
December 25, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Sty
Hazard: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
December 25, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style
Hazard: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
December 11, 2019Medical DevicesFDA
Allergan PLC recalls XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model
Hazard: Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH an
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast a
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Br
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstr
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast rec
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCe
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numb
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-12
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Ster
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
September 18, 2019Medical DevicesFDA
Allergan PLC recalls Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers:
Hazard: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
January 16, 2019DrugsFDA
Allergan, PLC. recalls OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only,
Hazard: GMP Deviations: A silicone particulate was noted in Ozurdex.
December 5, 2018DrugsFDA
ALLERGAN recalls INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose
Hazard: Failed Stability Specification: out of specification for iron content.
June 20, 2018DrugsFDA
Allergan, PLC. recalls Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: A
Hazard: Contraceptive Tablets Out of Sequence.
March 7, 2018DrugsFDA
ALLERGAN recalls INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (ND
Hazard: Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
February 21, 2018DrugsFDA
ALLERGAN recalls NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by:
Hazard: Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
January 17, 2018DrugsFDA
ALLERGAN recalls Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine,
Hazard: Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.