Drug Recalls, Withdrawals, and Safety Alerts

RxAdvance is committed to the safety and health of our members. As a service to our members, clients, pharmacies and prescribers, RxAdvance monitors drug recalls, withdrawals, and safety alerts communicated by the U.S. Food and Drug Administration (FDA), drug companies, drug distributors, and regulatory agencies. RxAdvance monitors these alerts closely to ensure that the drugs dispensed are safe for our members. RxAdvance will notify members and prescribers affected by these alerts.

Drug companies and the FDA issue recalls to protect the public from defective or potentially harmful drugs. These drug recalls are classified in the following manner:

  • Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
  • Class II recalls are for products that might cause a temporary health problem or pose only a slight threat of a serious nature.
  • Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA regulations.

The FDA may also issue safety alerts or drug withdrawals. In the event of a drug withdrawal, the drug will be removed from the drug formulary according to FDA guidance.
The alerts provided here include valuable information for your convenience.



Product NameAlert TypeManufacturerNotice Date
Guanfacine Extended-ReleaseSafety AlertApotex Corp03/31/2021


Product NameAlert TypeManufacturerNotice Date
Enoxaparin Sodium Injection, USPRecall AlertApotex Corp02/02/2021


Product NameAlert TypeManufacturerNotice Date
Cisatracurium Besylate InjectionRecall AlertMeitheal Pharmaceuticals, Inc. 01/27/2021
ketorolac tromethamine injectionRecall AlertFresenius Kabi USA, LLC01/08/2021
metformin hydrochloride ER tabletsRecall AlertNostrum Laboratories, Inc. 01/04/2021



Product NameAlert TypeManufacturerNotice Date
Paroex Chlorhexidine Gluconate Oral RinseRecall AlertPrecision Dose, Inc.12/31/2020
Paroex® Chlorhexidine Gluconate Oral RinseRecall AlertSunstar Americas, Inc. (SAI)12/28/2020
Sildenafil Tablets and Trazodone TabletsRecall AlertAvKARE, Pulaski, TN12/09/2020
Anagrelide CapsulesRecall AlertTorrent Pharmaceuticals Limited12/09/2020


Product NameAlert TypeManufacturerNotice Date
Dexmedetomidine Hydrochloride Injection Recall AlertFresenius Kabi USA11/19/2020
Chlorhexidine Gluconate Oral Rinse USPRecall AlertLohxa, LLC11/09/20202
Metformin Hydrochloride ER TabletsRecall AlertNostrum Laboratories, Inc.11/03/2020
metformin hydrochloride ER tabletsRecall AlertNostrum Laboratories, Inc.11/02/2020


Product NameAlert TypeManufacturerNotice Date
Paroex® (chlorhexidine gluconate) Oral Rinse USPRecall AlertSunstar Americas, Inc. (SAI)10/27/2020
Metformin Hydrochloride ER TabletsRecall AlertMarksans Pharma Limited10/05/2020


Product NameAlert TypeManufacturerNotice Date
Riomet ER™Recall AlertSun Pharmaceutical Industries, Inc. (Sun Pharma)09/23/2020
Albuterol Inhaler Recall AlertThe U.S. Food and Drug Administration (FDA)09/21/2020
NP Thyroid®Recall AlertAcella Pharmaceuticals, LLC 09/17/2020
Nature-Throid® and WP Thyroid®Recall AlertRLC Labs, Inc.09/03/2020


Product NameAlert TypeManufacturerNotice Date
Metformin Hydrochloride ER TabletsRecall AlertBayshore Pharmaceuticals, LLC08/20/2020
Heparin Sodium Compounded ProductsRecall AlertSCA Pharmaceuticals (SCA)08/18/2020
DDAVP®, desmopressin acetate and Stimate® Nasal SprayRecall AlertFerring Pharmaceuticals U.S. 08/05/2020


Product NameAlert TypeManufacturerNotice Date
Dexmedetomidine Hydrochloride Injection Recall AlertFresenius Kabi USA07/22/2020
Metformin Hydrochloride ER Tablets Recall AlertLupin Pharmaceuticals Inc. 07/08/2020
Daptomycin for InjectionRecall AlertMylan07/07/2020
Metformin Hydrochloride ER TabletsRecall AlertGranules Pharmaceuticals, Inc.07/03/2020


Product NameAlert TypeManufacturer Date of Notice
Children’s Robitussin and Children’s DimetappRecall AlertGSK Consumer Healthcare06/18/2020
Metformin Hydrochloride ER TabletsRecall AlertMarksans Pharma Limited06/02/2020
Metformin Hydrochloride ER TabletsRecall AlertTeva Pharmaceuticals USA, Inc.06/02/2020
Epinephrine Auto-Injector DevicesSafety AlertAmneal and Impax epinephrine06/01/2020


Product NameAlert TypeManufacturer Date of Notice
Metformin Hydrochloride ER TabletsRecall AlertAmneal Pharmaceuticals LLC05/29/2020
Metformin Hydrochloride ER TabletsRecall AlertApotex Corp05/27/2020
NP ThyroidRecall AlertAcella Pharmaceuticals LLC05/22/2020
Lactated Ringer’s InjectionRecall AlertICU Medical Inc05/08/2020
Finasteride Plus 1.25mgRecall AlertMasterPharm LLC05/06/2020


Product NameAlert TypeManufacturer Date of Notice
ChloroquineSafety AlertAll Manufacturers04/24/2020
HydroxychloroquineSafety AlertAll Manufacturers04/24/2020
Ketorolac InjectionRecall AlertFresenius Kabi04/20/2020
True Metrix Air Blood Glucose MeterRecall AlertTrividia Health Inc04/20/2020
Ranitidine capsulesWithdrawal AlertStrides Pharma04/17/2020
Nizatidine oral solutionRecall AlertAmneal Pharmaceuticals LLC04/15/2020
Tetracycline capsulesRecall AlertAvet Pharmaceutics Inc04/15/2020
LimbrelRecall AlertPrimus Pharmaceuticals04/13/2020
Ranitidine syrupWithdrawal AlertPharmaceutical Associates04/07/2020
Ranitidine (Zantac) Withdrawal AlertAll Manufacturers04/01/2020


Product NameAlert TypeManufacturerDate of Notice
Phytonadione injectableRecall AlertDr. Reddy Laboratories03/26/2020
EpiPen and genericsSafety AlertPfizer and Mylan03/24/2020
Ketorolac InjectionRecall AlertHikma Pharmaceuticals03/04/2020
Montelukast (Singulair)Safety AlertAll Manufacturers03/04/2020


Product NameAlert TypeManufacturer Date of Notice
Phenytoin Oral SuspensionRecall AlertTaro Pharmaceuticals02/20/2020
Belviq and Belviq XRWithdrawal AlertEisai02/13/2020


Product NameAlert TypeManufacturer Date of Notice
Clozapine (Clozaril-Fazaclo and Versacloz)Safety AlertAll Manufacturers01/28/2020
Lamotrigine TabletsRecall AlertTaro Pharmaceuticals01/10/2020
Nizatidine capsulesRecall AlertMylan01/08/2020
Ranitidine capsulesRecall AlertAppco Pharma01/07/2020
Ranitidine tabletsRecall AlertDenton Pharma Inc01/06/2020