AvPAK

Pharmaceutical company2 products tracked

products tracked

22,105

total reports

recalls on record

63.2%

serious overall

Products

showing 2 of 2

Product	Approved	Reports ↓	Top signal	Recalls
isosorbide dinitrate —	1968	19,613	Transient ischaemic attack	8
artificial tears —	—	2,492	Endocrine ophthalmopathy	20

Recall history · 26 on record

Date	Class	Reason	Firm
Mar 25, 2026	II	Lack of Assurance of Sterility	Preferred Pharmaceuticals, Inc.
Mar 3, 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
Mar 3, 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
Apr 23, 2025	II	cGMP deviations and lack of assurance of sterility.	BRS Analytical Services, LLC
Jun 13, 2023	II	CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.	K.C. Pharmaceuticals, Inc
Apr 26, 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
Jan 30, 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
Jan 30, 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
Jan 30, 2023	II	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.	Global Pharma Healthcare Private Limited
Jan 30, 2023	II	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.	Global Pharma Healthcare Private Limited
Oct 13, 2022	II	CGMP Deviations:	Akorn, Inc.
Oct 13, 2022	II	CGMP Deviations:	Akorn, Inc.
Aug 2, 2021	II	Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.	Akorn, Inc.
Nov 2, 2018	II	Cross Contamination with Other Products	Sandoz Inc
Nov 2, 2018	II	Cross Contamination with Other Products	Sandoz Inc
Nov 2, 2018	II	Cross Contamination with Other Products	Sandoz Inc
Nov 2, 2018	II	Cross Contamination with Other Products	Sandoz Inc
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
Jul 2, 2013	II	Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.	Aidapak Services, LLC
Jul 2, 2013	II	Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.	Aidapak Services, LLC
Jul 2, 2013	II	Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.	Aidapak Services, LLC
May 25, 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 because 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
May 25, 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 because 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
May 25, 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 because 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
May 25, 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 because 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
May 25, 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 because 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 AvPAK 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.