Allergan, Inc.

Pharmaceutical company14 products tracked

products tracked

339,204

total reports

recalls on record

44.3%

serious overall

Products

showing 14 of 14

Product	Approved	Reports ↓	Top signal	Recalls
prednisolone —	1955	188,016	Cytomegalovirus infection	33
onabotulinumtoxina —	1991	75,403	Multiple use of single-use product	0
linaclotide —	2012	25,697	Flatulence	1
prednisolone acetate —	1955	10,056	Endophthalmitis	8
cariprazine —	2015	8,903	Akathisia	1
brimonidine tartrate, timolol maleate —	—	6,551	Intraocular pressure increased	5
milnacipran hydrochloride —	2009	5,952	Fibromyalgia	0
ubrogepant —	2019	5,632	Migraine	0
norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate —	—	3,150	Amenorrhoea	0
eluxadoline —	2015	2,902	Contraindicated drug prescribed	0
carboxymethylcellulose sodium and glycerin —	—	2,372	Scleral hyperaemia	0
levomilnacipran hydrochloride —	2013	1,881	Overlap syndrome	0
gatifloxacin —	2003	1,747	Toxic anterior segment syndrome	13
carboxymethylcellulose sodium, glycerin, and polysorbate 80 —	—	942	Eyelid pain	0

Recall history · 39 on record

Date	Class	Reason	Firm
May 18, 2026	III	Failed Stability Specifications	AbbVie Inc.
Apr 26, 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
Oct 7, 2022	II	Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.	Pharmacy Plus, Inc. dba Vital Care Compounder
Aug 1, 2022	II	Defective Container: Product has incomplete induction seals.	Akorn, Inc
Apr 13, 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
Dec 22, 2021	III	Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.	Lupin Pharmaceuticals Inc.
Oct 20, 2021	III	Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.	Lupin Pharmaceuticals Inc.
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Jun 5, 2020	III	Discoloration: Out of Specification (OOS) result for APHA Color Test.	Akorn, Inc.
Oct 17, 2019	III	Labeling: Incorrect or missing package insert.	Sandoz Inc
Sep 23, 2019	II	Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14	Morton Grove Pharmaceuticals, Inc.
Sep 6, 2019	III	Failed Impurities/Degradation Specifications:OOS for unknown impurity.	Mylan Pharmaceuticals Inc.
Jul 11, 2019	III	Labeling: Missing label; Product complaints reported missing bottle label.	Lupin Pharmaceuticals Inc.
Dec 17, 2018	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Dec 17, 2018	II	Lack of sterility assurance.	Promise Pharmacy, LLC
Oct 18, 2018	III	Presence of precipitate	Promise Pharmacy LLC
Jul 24, 2018	II	Defective Container: Tamper Evident foil seal not completely intact.	Morton Grove Pharmaceuticals, Inc.
Apr 30, 2018	II	CGMP Deviations	Mylan Pharmaceuticals Inc.
Apr 30, 2018	II	CGMP Deviations	Mylan Pharmaceuticals Inc.
Apr 30, 2018	II	CGMP Deviations	Mylan Pharmaceuticals Inc.
Nov 16, 2017	II	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.	KRS Global Biotechnology, Inc
May 1, 2017	II	Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.	Allergan Sales, LLC
Mar 28, 2017	III	Failed Stability Specifications	Teva Pharmaceuticals USA
Sep 20, 2016	II	Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters	Leiter's Compounding
Sep 12, 2015	II	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.	US Compounding Inc
Aug 24, 2015	II	Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.	Allergan Sales, LLC
Nov 14, 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
Nov 14, 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
Nov 14, 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
Nov 14, 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
Oct 6, 2014	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Oregon Compounding Centers, Inc. dba Creative Compounds
Aug 27, 2014	II	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.	Martin Avenue Pharmacy, Inc.
Oct 19, 2013	II	Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.	Specialty Medicine Compounding Pharmacy
Jul 2, 2013	II	Labeling: Label Mixup; prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: W003644, EXP: 8/24/2013.	Aidapak Services, LLC
May 21, 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Allergan, Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.