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ANI Pharmaceuticals, Inc.

Pharmaceutical company4 products tracked
4
products tracked
56,665
total reports
20
recalls on record
76.9%
serious overall
Products
showing 4 of 4
ProductApprovedReports ↓Top signalRecalls
199120,266Angina pectoris3
199716,862Chronic kidney disease10
195510,329Myasthenia gravis crisis4
19719,208Immune reconstitution inflammatory syndrome associated tuberculosis3
Recall history · 29 on record
DateClassReasonFirm
Jun 2, 2026IIIPresence of foreign substanceANI Pharmaceuticals, Inc.
May 1, 2023IICGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.RemedyRepack Inc.
Sep 16, 2022IIIFailed Viscosity specification: Slightly higher OOS results obtained for viscosityALMIRALL, LLC
Apr 13, 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
Feb 15, 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
Feb 15, 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
Feb 15, 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
Feb 15, 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
Feb 15, 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
Oct 9, 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
Oct 9, 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
Oct 9, 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
Oct 9, 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
Oct 9, 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
Oct 9, 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
Feb 9, 2018IICGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.American Pharmaceutical Ingredients LLC
Feb 10, 2017IILack of Assurance of Sterility: There are also CGMP Deviations.Synergy Rx
Feb 10, 2017IILack of Assurance of Sterility: There are also CGMP Deviations.Synergy Rx
Nov 14, 2014IIPenicillin 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, 2014IIPenicillin 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, 2014IIPenicillin 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
Dec 13, 2013IIFailed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.Corepharma LLC
Nov 18, 2013IIIFailed Impurities/Degradation Specifications: Out-of-Specification degradant results.Fougera Pharmaceuticals Inc.
Sep 23, 2013IIISubpotentTolmar, Inc.
Jul 2, 2013IILabeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014.Aidapak Services, LLC
Jul 2, 2013IILabeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383Aidapak Services, LLC
Jul 2, 2013IILabeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD28322_10, EXP: 5/6/2014.Aidapak Services, LLC
Jul 2, 2013IIFailed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.Core Pharma Llc
Jul 18, 2012IIIFailed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant productFougera Pharmaceuticals Inc.

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

Registration status

Some products from ANI Pharmaceuticals, 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.