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Manufacturer profile

Advagen Pharma Ltd.

Pharmaceutical company3 products tracked
3
products tracked
255,687
total reports
128
recalls on record
56.5%
serious overall
Products
showing 3 of 3
ProductApprovedReports ↓Top signalRecalls
1990189,078Asthma19
—37,381Asthma100
—29,228Asthma9
Recall history · 50 on record
DateClassReasonFirm
Apr 8, 2026IIDefective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.Apotex Corp.
Dec 12, 2025IMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.Medinatura New Mexico, inc.
Dec 12, 2025IMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.Medinatura New Mexico, inc.
Feb 14, 2024IICGMP Deviations:Suspected potential presence of Burkholderia cepacia complexGolden State Medical Supply Inc.
Feb 9, 2024IICGMP Deviations: potential presence of Burkholderia cepacia complexApotex Corp.
Dec 28, 2023IICGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.Seaway Pharma Inc.
Dec 28, 2023IICGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.Seaway Pharma Inc.
Apr 26, 2023IICGMP Deviations: Firm went out of business and could no longer continue stability studies.Akorn, Inc.
Feb 23, 2023IICGMP Deviations: Raw material recalled by repackager, due to discoloration.Nutraceutical Corporation
Feb 23, 2023IICGMP Deviations: Raw material recalled by repackager, due to discoloration.Nutraceutical Corporation
Jun 13, 2022IIDefective container: defect prevents product from dispensing as intended.Akorn, Inc.
Jan 26, 2022IICGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.CARDINAL HEALTHCARE
Jan 26, 2022IICGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.CARDINAL HEALTHCARE
Jan 26, 2022IICGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.CARDINAL HEALTHCARE
Jan 24, 2022IIcGMP deviationsUltra Seal Corporation
Oct 26, 2021IICGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC
Oct 26, 2021IICGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC
Oct 26, 2021IICGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC
Oct 26, 2021IICGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC
Oct 26, 2021IICGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC
Oct 26, 2021IICGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC
Oct 26, 2021IICGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC
Sep 22, 2021IISubpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolTeva Pharmaceuticals USA
Sep 22, 2021IISubpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolTeva Pharmaceuticals USA
Sep 22, 2021IISubpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolTeva Pharmaceuticals USA
Sep 22, 2021IISubpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolTeva Pharmaceuticals USA
Sep 22, 2021IISubpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolTeva Pharmaceuticals USA
Mar 15, 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
May 21, 2019IIcGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).Torrent Pharma Inc
May 21, 2019IIcGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).Torrent Pharma Inc
Aug 3, 2018IICGMP Deviations: products manufactured under conditions that could impact its product quality.Product Quest Manufacturing LLC
Aug 3, 2018IICGMP Deviations: products manufactured under conditions that could impact its product quality.Product Quest Manufacturing LLC
Aug 3, 2018IICGMP Deviations: products manufactured under conditions that could impact its product quality.Product Quest Manufacturing LLC
Aug 3, 2018IICGMP Deviations: products manufactured under conditions that could impact its product quality.Product Quest Manufacturing LLC
Aug 3, 2018IICGMP Deviations: products manufactured under conditions that could impact its product quality.Product Quest Manufacturing LLC
Aug 3, 2018IMicrobial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.Product Quest Manufacturing LLC
May 31, 2018IIPresence of foreign substance: glass particlesApotex 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
Jul 5, 2016IIMarketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.Let's Talk Health, Inc.
Feb 27, 2015IIFailed Stability Specifications: Out of specification for preservative, benazalkonium chloride.Akorn, Inc.
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
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Jan 30, 2013IICGMP Deviations: Products are underdosed or have an incorrect dosage regime.TG United, Inc.
Dec 18, 2012IMicrobial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.Matrixx Initiatives Inc

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

Registration status

Some products from Advagen Pharma Ltd. 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.