Asclemed USA, Inc.

Pharmaceutical company6 products tracked

products tracked

333,041

total reports

recalls on record

64.0%

serious overall

Products

showing 6 of 6

Product	Approved	Reports ↓	Top signal	Recalls
acetaminophen tablet extended release —	—	246,995	Infusion related reaction	0
valacyclovir hydrochloride —	1995	68,558	Cytokine release syndrome	0
ivermectin —	1996	6,095	Strongyloidiasis	1
ketorolac tromethamine —	1992	5,509	Nasal discomfort	33
metaxalone —	1962	3,299	Completed suicide	2
meclizine hydrocloride —	—	2,585	Vertigo	0

Recall history · 32 on record

Date	Class	Reason	Firm
Oct 1, 2025	II	Presence of Particulate Matter: Particulate matter identified as glass	Aspiro Pharma Limited
Sep 5, 2025	II	Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns	Apotex Corp.
May 28, 2025	II	Lack of Assurance of Sterility	Apotex Corp.
Apr 26, 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
Oct 13, 2022	II	CGMP Deviations:	Akorn, Inc.
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Dec 23, 2020	I	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
Dec 17, 2020	II	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
Apr 20, 2020	II	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
Apr 20, 2020	I	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
Dec 17, 2019	I	Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)	Hikma Pharmaceuticals USA Inc.
Dec 17, 2019	II	Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)	Hikma Pharmaceuticals USA Inc.
Sep 12, 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
Sep 12, 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
Sep 12, 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
Apr 30, 2019	II	Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.	Sagent Pharmaceuticals Inc
Aug 15, 2017	II	Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.	Amphastar Pharmaceuticals, Inc.
Jun 30, 2015	II	Crystallization; identified as calcium salt of Ketorolac	Hospira Inc.
Jun 30, 2015	II	Crystallization; identified as calcium salt of Ketorolac	Hospira Inc.
Apr 13, 2015	II	Crystallization	Hospira Inc.
Apr 13, 2015	II	Crystallization	Hospira Inc.
Jan 23, 2015	II	Crystallization	Hospira Inc.
Jan 23, 2015	II	Crystallization	Hospira Inc.
Jan 21, 2015	II	Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.	Sun Pharma Global Fze
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	Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.	Hospira Inc.
Oct 3, 2014	II	Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.	Sagent Pharmaceuticals Inc
Aug 12, 2013	II	Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.	Hospira, Inc.
Jul 26, 2013	II	Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance	Beacon Hill Medical Pharmacy, P.C.
Jul 2, 2013	II	Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014.	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 Asclemed USA, 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.