Cipla USA Inc.,

Pharmaceutical company2 products tracked

products tracked

597,398

total reports

105

recalls on record

71.1%

serious overall

Products

showing 2 of 2

Product	Approved	Reports ↓	Top signal	Recalls
calcium —	1982	592,039	Type 2 diabetes mellitus	100
calcium acetate —	1982	5,359	Chronic kidney disease-mineral and bone disorder	5

Recall history · 50 on record

Date	Class	Reason	Firm
Jul 30, 2025	II	Lack of Assurance of Sterility	GenoGenix LLC
Oct 2, 2023	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
Aug 17, 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
Aug 17, 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
Aug 11, 2023	II	Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.	Baxter Healthcare Corporation
Jul 14, 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
Jun 23, 2023	I	Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test	Lupin Pharmaceuticals Inc.
Apr 28, 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
Dec 22, 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
Dec 22, 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
May 18, 2022	II	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC
Mar 16, 2022	III	Failed Impurities/Degradation Specifications: Out of Specification results for related substance.	Dr. Reddy's Laboratories, Inc.
Jul 29, 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
Apr 26, 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
Mar 15, 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
Jun 19, 2019	II	Lack of Assurance of Sterility	RXQ Compounding LLC
Feb 13, 2018	III	Presence of Foreign Tablets/Capsules	Nostrum Laboratories Inc
Feb 22, 2017	II	Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.	Advanced Pharma Inc.
Nov 18, 2016	II	Lack of Assurance of Sterility - the firm is recalling select sterile drug products.	Cantrell Drug Company
Nov 18, 2016	II	Lack of Assurance of Sterility - the firm is recalling select sterile drug products.	Cantrell Drug Company
Jul 18, 2016	II	Penicillin Cross Contamination	GlaxoSmithKline, LLC
Jul 7, 2016	II	CGMP Deviations	Safecor Health, LLC
Jun 20, 2016	II	Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.	W & C dba The Apothecary
Jun 20, 2016	II	Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.	W & C dba The Apothecary
Dec 18, 2015	III	Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.	National Vitamin Co Inc
Oct 19, 2015	II	Lack of Assurance of Sterility	Western Drug
Aug 13, 2015	II	Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.	GlaxoSmithKline, LLC.
Aug 13, 2015	II	Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.	GlaxoSmithKline, LLC.
Jul 24, 2015	II	Lack of Assurance of Sterility; all sterile human compounded drugs within expiry	JD & SN Inc., dba Moses Lake Professional Pharmacy
May 28, 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
May 28, 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
Jan 8, 2015	III	Subpotent Drug	Freedom Pharmaceuticals Inc
Dec 17, 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, 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
Aug 7, 2014	I	Presence of Particulate Matter: particulate matter was found during the manufacturing process.	Baxter Healthcare Corp.
Apr 14, 2014	II	Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..	Fresenius Medical Care Holdings, Inc.
Oct 19, 2013	II	Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.	Specialty Medicine Compounding Pharmacy
Aug 9, 2013	I	Non Sterility: Microbial contamination	Specialty Compounding, LLC
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.

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

Registration status

Some products from Cipla 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.