Chartwell RX, LLC

Pharmaceutical company8 products tracked

products tracked

358,763

total reports

recalls on record

72.8%

serious overall

Products

showing 8 of 8

Product	Approved	Reports ↓	Top signal	Recalls
escitalopram —	2002	136,935	Suicide attempt	2
leflunomide —	1998	102,951	Anti-cyclic citrullinated peptide antibody positive	4
diazepam oral solution (concentrate) —	—	87,168	Drug abuse	1
posaconazole delayed-release —	—	10,528	Mucormycosis	1
cimetidine —	1977	9,348	End stage renal disease	3
sterile water —	1970	4,851	Hereditary angioedema	72
cyproheptadine hydrochloride —	1979	4,297	Infective pulmonary exacerbation of cystic fibrosis	2
bupropion hydrochloride (xl) —	—	2,685	Product substitution issue	0

Recall history · 39 on record

Date	Class	Reason	Firm
Apr 2, 2026	II	Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.	B BRAUN MEDICAL INC
Dec 22, 2025	II	Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution	Baxter Healthcare Corporation
Aug 26, 2025	II	Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.	B BRAUN MEDICAL INC
Apr 26, 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
Apr 13, 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
Apr 4, 2022	II	CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated	Olympia Compounding Pharmacy dba Olympia Pharmacy
Jul 29, 2021	II	Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.	PAI Holdings, LLC. dba Pharmaceutical Associates Inc
May 3, 2021	II	Presence of Particulate Matter: particulate matter identified as an insect in one vial.	Pfizer Inc.
Jun 19, 2019	II	Lack of Assurance of Sterility	RXQ Compounding LLC
May 21, 2019	II	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).	Torrent Pharma Inc
Mar 13, 2019	II	Lack of Assurance of Sterility	Advanced Pharma Inc.
Nov 29, 2018	I	Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".	Advanced Pharma Inc.
Sep 10, 2018	II	Lack of Assurance of Sterility	Pharm D Solutions, LLC
Dec 27, 2017	II	Lack of sterility assurance.	Pharmedium Services, LLC
Sep 1, 2017	II	Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.	Pfizer Inc.
Sep 20, 2016	II	Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters	Leiter's Compounding
Aug 16, 2016	I	Non Sterility; contaminated with Klebsiella pneumoniae	Sperian Eye & Face Protection, Inc
Jun 7, 2016	III	Subpotency: product assayed and found OOS for cyproheptadine	Lyne Laboratories, Inc.
Apr 20, 2016	II	Lack of Assurance of Sterility	Pharmakon Pharmaceuticals, Inc.
Apr 18, 2016	II	Lack of Sterility Assurance	Baptist Health Medical Towers Pharmacy and Infusion Services
Mar 24, 2016	III	Labeling: Incorrect or Missing Lot and/or Expiration Date	Lupin Limited
Feb 16, 2016	II	Presence of Particulate Matter: Glass particles found in the product after reconstitution.	Genzyme Corporation
May 28, 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
May 18, 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
May 18, 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
May 18, 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
May 18, 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
Dec 26, 2014	II	Lack of sterility assurance.	Walgreens Infusion Services
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 14, 2014	II	Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.	Hospira Inc.
May 15, 2014	II	Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.	Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014	II	Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.	Franck's Lab Inc dba Trinity Care Solutions
Apr 29, 2014	II	Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.	Flawless Beauty LLC
Oct 19, 2013	I	Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.	Specialty Medicine Compounding Pharmacy, P.C.
Jul 2, 2013	II	Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014.	Aidapak Services, LLC
Jul 2, 2013	II	Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the following drug: SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003707, EXP: 6/25/2014.	Aidapak Services, LLC
Jun 14, 2007	II	Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.	Apotex Corp.
Jun 14, 2007	II	Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.	Apotex Corp.

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

Registration status

Some products from Chartwell RX, LLC 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.