Recent Voluntary Drug Recalls

Ranitidine Capsules, Tablets and Oral Solution

On December 17, 2019, Glenmark Pharmaceutical Inc., manufacturer of ranitidine, issued a voluntary recall of ranitidine tablets. This recall was issued because an unexpected impurity was found in these products that may cause health risks.

What do you need to do?

Do not stop taking your medication without speaking with your doctor. The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption.

For more information or to report any adverse events or quality problems experienced with the use of this product directly to Glenmark Drug Safety or you can report to the FDA's MedWatch Program.

Manufacturers:
- Glenmark Drug Safety: Glenmark customer service center at 1.888.721.7115, Monday thru Friday, 9 a.m. – 6 p.m., US EST, or via email at GlobalCustomerService@glenmarkpharma.com.
To report an adverse event to the FDA Med Watch Program:
- Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
- Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda or submit by fax to 1-800-FDA-0178

Affected NDCs:

Product	NDC #	Affected Lots
Ranitidine 150 mg tablets	68462-0248-05	All Unexpired Lots
	68462-0249-01
	68462-0248-60
	68462-0248-01
Ranitidine 300 mg tablets	68462-0249-30	All Unexpired Lots
	68462-0249-20

On October 23, and November 12, 2019, Amneal Pharmaceuticals, LLC., Aurobindo Pharma USA, Inc., Dr. Reddy’s Laboratories Ltd., Lannett Company, Inc., and Novitium Pharma, manufacturers of ranitidine, issued a voluntary recall of ranitidine capsules, oral solution and tablets. This recall was issued because an unexpected impurity was found in these products that may cause health risks.

What do you need to do?

Do not stop taking your medication without speaking with your doctor. The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption.

For more information or to report any adverse events or quality problems experienced with the use of this product directly to Dr. Reddy’s Laboratories Ltd., Lannett Company, Inc., Novitium Pharma., or you can report to the FDA's MedWatch Program.

Manufacturers:
- Amneal: Call Stericycle at 866.918.8768, Monday through Friday, from 8 a.m. to 5 p.m., EST.
- Aurobindo Pharma USA, Inc. at 866.850.2876, option 2 or via email at pvg@aurobindousa.com
- Dr. Reddy’s Laboratories Ltd. Medical Information Call Center at 888.375-3784, available Monday through Friday, 8 a.m. – 8 p.m. EST.
- Lannett Company, Inc. at 215.333.9000, extension 4 or via email at customerservice@lannett.com.
- Novitium Pharma at 609.469.5920, or via email at info@novitiumpharma.com.
To report an adverse event to the FDA Med Watch Program:
- Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
- Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda or submit by fax to 1-800-FDA-0178

Dr. Reddy’s Laboratories Ltd Voluntarily Recalled Products:

Description	Strength	Type	Pack	NDC (National Drug Codes)
Ranitidine Capsules	150 mg	Rx	60 count bottle	5511112960
Ranitidine Capsules	150 mg	Rx	500 count bottle	5511112905
Ranitidine Capsules	300 mg	Rx	30 count bottle	5511113030
Ranitidine Capsules	300 mg	Rx	100 count bottle	5511113001
Ranitidine Tablets, USP (Sam’s Club)	150 mg	OTC	190 count (2x95) tray	150062076
Ranitidine Tablets, USP (Walgreens)	150 mg	OTC	95 count bottle	0363-0010-62
Ranitidine Tablets, USP (Walmart)	150 mg	OTC	220 count bottle	49035-404-65
Ranitidine Tablets, USP (Kroger)	150 mg	OTC	50 count bottle	30142-505-50
Ranitidine Tablets, USP (Kroger)	150 mg	OTC	24 count bottle	30142-505-34
Ranitidine Tablets, USP (Walgreens)	150 mg	OTC	65 count bottle	0363-0010-61
Ranitidine Tablets, USP CP32 (Walmart)	150 mg	OTC	65 count bottle	49035-404-61
Ranitidine Tablets, USP (Walgreens)	150 mg	OTC	200 count bottle	0363-0010-01
Ranitidine Tablets, USP (Walgreens)	150 mg	OTC	24 count bottle	0363-0010-34
Ranitidine Tablets, USP NG (CVS)	75 mg	OTC	30 count bottle	69842-871-30
Ranitidine Tablets, USP (Walgreens)	75 mg	OTC	30 count bottle	0363-0131-30
Ranitidine Tablets, USP (Walgreens)	75 mg	OTC	80 count bottle	0363-0131-80
Ranitidine Tablets, USP NG (CVS)	75 mg	OTC	80 count bottle	69842-871-80
Ranitidine Tablets, USP NG (CVS)	75 mg	OTC	160 count bottle	69842-871-37
Ranitidine Tablets, USP (Kroger)	75 mg	OTC	30 count bottle	30142-131-30
Ranitidine Tablets, USP (CDMA)	150 mg	OTC	24 count bottle	63868-480-24
Ranitidine Tablets, USP NV (Walmart)	150 mg	OTC	130 count bottle	49035-404-13
Ranitidine Tablets, USP (CDMA)	150 mg	OTC	50 count bottle	63868-480-50
Ranitidine Tablets, USP (Dr. Reddy’s)	75 mg	OTC	60 count bottle	55111-131-60
Ranitidine Tablets, USP (CDMA)	75 mg	OTC	60 count bottle	63868-482-60
Ranitidine Tablets, USP (CDMA)	75 mg	OTC	30 count bottle	63868-482-30
Ranitidine Tablets, USP (Dr. Reddy’s)	150 mg	OTC	24 count bottle	55111-404-34
Ranitidine Tablets, USP (HCA)	150 mg	OTC	95 count bottle	43598-808-62
Ranitidine Tablets, USP (HCA)	150 mg	OTC	220 count bottle	43598-808-65
Ranitidine Tablets, USP (Target)	150 mg	OTC	40 count bottle	11673-849-40
Ranitidine Tablets, USP (Thirty Madison)	150 mg	OTC	24 count bottle	71713-203-02
Ranitidine Tablets, USP (Thirty Madison)	150 mg	OTC	95 count bottle	71713-203-05
Ranitidine Tablets, USP (GeriCare)	75 mg	OTC	All counts	57896-715
Ranitidine Tablets, USP (GeriCare)	150 mg	OTC	All counts	57896-717

Lannett Company, Inc. Voluntarily Recalled Ranitidine Syrup (oral solution) 15mg/mL:

NDC Code	Batch	Expiration Date (Month/Year)	NDC Code	Batch	Expiration Date (Month/Year)
54838-550-80	1503A	Oct./2019	54838-550-80	1646A	Feb./2020
54838-550-80	1504A	Oct./2019	54838-550-80	1647A	Feb./2020
54838-550-80	1505A	Oct./2019	54838-550-80	1668A	Mar./2020
54838-550-80	1523A	Oct./2019	54838-550-80	1669A	Mar./2020
54838-550-80	1524A	Oct./2019	54838-550-80	1670A	Mar./2020
54838-550-80	1525A	Nov./2019	54838-550-80	1708A	Mar./2020
54838-550-80	1561A	Dec./2019	54838-550-80	1709A	Apr./2020
54838-550-80	1562A	Dec./2019	54838-550-80	1710A	Apr./2020
54838-550-80	1563A	Dec./2019	54838-550-80	1729A	Apr./2020
54838-550-80	1589A	Dec./2019	54838-550-80	1730A	Apr./2020
54838-550-80	1590A	Dec./2019	54838-550-80	1731A	Apr./2020
54838-550-80	1591A	Dec./2019	54838-550-80	1757A	May./2020
54838-550-80	1614A	Jan./2020	54838-550-80	1758A	May./2020
54838-550-80	1615A	Jan./2020	54838-550-80	1759A	May./2020
54838-550-80	1617A	Jan./2020	54838-550-80	1773A	Jun./2020
54838-550-80	1644A	Feb./2020	54838-550-80	1774A	Jun./2020
54838-550-80	1775A	Jun./2020	54838-550-80	1989A	Dec./2020
54838-550-80	1794A	Jun./2020	54838-550-80	1990A	Dec./2020
54838-550-80	1795A	Jun./2020	54838-550-80	1991A	Dec./2020
54838-550-80	1796A	Jun./2020	54838-550-80	1998A	Jan./2021
54838-550-80	1817A	Jun./2020	54838-550-80	1999A	Jan./2021
54838-550-80	1818A	Jul./2020	54838-550-80	2000A	Jan./2021
54838-550-80	1819A	Jul./2020	54838-550-80	2019A	Jan./2021
54838-550-80	1840A	Aug./2020	54838-550-80	2020A	Jan./2021
54838-550-80	1840B	Aug./2020	54838-550-80	2065A	Mar./2021
54838-550-80	1841A	Aug./2020	54838-550-80	2066A	Mar./2021
54838-550-80	1842A	Aug./2020	54838-550-80	2067A	Mar./2021
54838-550-80	1863A	Aug./2020	54838-550-80	2071A	Mar./2021
54838-550-80	1864A	Sep./2020	54838-550-80	2072A	Mar./2021
54838-550-80	1865A	Sep./2020	54838-550-80	2073A	Mar./2021
54838-550-80	1899A	Oct./2020	54838-550-80	2076A	Mar./2021
54838-550-80	1900A	Oct./2020	54838-550-80	2077A	Mar./2021
54838-550-80	1901A	Oct./2020	54838-550-80	2078A	Mar./2021
54838-550-80	1910A	Oct./2020	54838-550-80	2126A	May./2021
54838-550-80	1911A	Oct./2020	54838-550-80	2127A	May./2021
54838-550-80	1912A	Oct./2020	54838-550-80	2128A	May./2021
54838-550-80	1918A	Oct./2020	54838-550-80	2164A	Jun./2021
54838-550-80	1919A	Oct./2020	54838-550-80	2165A	Jun./2021
54838-550-80	1920A	Oct./2020	54838-550-80	2166A	Jun./2021
54838-550-80	1925A	Oct./2020	54838-550-80	2179A	Jun./2021
54838-550-80	1926A	Oct./2020	54838-550-80	2180A	Jul./2021
54838-550-80	1927A	Oct./2020	54838-550-80	2181A	Jul./2021
54838-550-80	1977A	Dec./2020	54838-550-80	2214A	Aug./2021
54838-550-80	1978A	Dec./2020	54838-550-80	2215A	Aug./2021
54838-550-80	1979A	Dec./2020	54838-550-80	2216A	Aug./2021

Novitium Pharma Voluntarily Recalled Products:

Description	Strength	Type	Pack Size	NDC
Ranitidine Capsules	150 mg	Rx	60 count bottle	70954-001-20
Ranitidine Capsules	150 mg	Rx	500 count bottle	70954-001-40
Ranitidine Capsules	300 mg	Rx	30 count bottle	70954-002-10
Ranitidine Capsules	300 mg	Rx	100 count bottle	70954-002-40

Amneal Pharmaceuticals, LLC. Voluntarily Recalled Products:

Product	Strength	NDC Number
Ranitidine Tablets, USP	150 mg	65162-253-06
Ranitidine Tablets, USP	150 mg	65162-253-10
Ranitidine Tablets, USP	150 mg	65162-253-18
Ranitidine Tablets, USP	150 mg	65162-253-50
Ranitidine Tablets, USP	150 mg	65162-253-11
Ranitidine Tablets, USP	300 mg	65162-254-03
Ranitidine Tablets, USP	300 mg	65162-254-10
Ranitidine Tablets, USP	300 mg	65162-254-25
Ranitidine Tablets, USP	300 mg	65162-254-11
Ranitidine Tablets, USP	150 mg	53746-253-05
Ranitidine Tablets, USP	150 mg	53746-253-10
Ranitidine Syrup (Ranitidine Oral Solution, USP)	15 mg/mL; 16 fl. oz.	65162-664-90

Aurobindo Pharma USA, Inc. Voluntarily Recalled Products:

Product Name	NDC	Exp. Date
Ranitidine Tablets 150mg	55910-092-79	Feb-21
Ranitidine Capsules 150mg	59651-144-60	Jul-20
	59651-144-60	Jul-20
	59651-144-05	Jul-20
		Jul-20
		Aug-20
		Aug-20
	59651-144-60	Aug-20
	59651-144-60	Aug-20
	59651-144-05	Sep-20
		Sep-20
		Sep-20
		Oct-20
		Nov-20
		Nov-20
		Nov-20
		Nov-20
		Nov-20
	59651-144-60	May-21
	59651-144-05	May-21
	59651-144-05	May-21
Ranitidine Capsules 300mg	59651-145-30	Jul-20
		Jul-20
		Jul-20
		Aug-20
		Aug-20
		Aug-20
		Sep-20
		Sep-20
		Sep-20
		Oct-20
		Jan-21
		Jan-21
		May-21
Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg/5 mL)	65862-431-74	May-21
		May-21
		May-21
		May-21

NATPARA® (parathyroid hormone) for Injection

On September 5, 2019 Takeda Pharmaceutical Company Limited, manufacturer of NATPARA® (parathyroid hormone) for Injection, issued a voluntary recall of all lots of this product. This recall was issued because of the potential risk of rubber particles in the cartridge. Small pieces of rubber may break off when the rubber septum is punctured multiple times for repeated doses.

Affected NDCs

Product Name	NDC #	Lot #
NATPARA^® (Parathyroid Hormone) for Injection 25 mcg	68875-0202-01 68875-0202-02	All
NATPARA^® (Parathyroid Hormone) for Injection 50 mcg	68875-0203-01 68875-0203-02	All
NATPARA^® (Parathyroid Hormone) for Injection 75 mcg	68875-0204-01 68875-0204-02	All
NATPARA^® (Parathyroid Hormone) for Injection 100 mcg	68875-0205-01 68875-0205-02	All

What do you need to do?

Do not stop taking your medication without speaking with your doctor. The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, because of the potential risk of harm to a patient's health if the treatment is stopped immediately without any alternative treatment.
Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption.

For more information

For more information, if you have not already been contacted by Takeda or to report any adverse events or quality problems experienced with the use of this product, contact Takeda Pharmaceuticals Limited toll free at 1.866.888.0660 or visit www.takeda.com. You can also report this to the FDA's MedWatch Program.

To report an adverse event to the FDA Med Watch Program:

Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda or submit by fax to 1-800-FDA-0178

Recent Voluntary Drug Recalls

Ranitidine Capsules, Tablets and Oral Solution

What do you need to do?

Affected NDCs:

What do you need to do?

Dr. Reddy’s Laboratories Ltd Voluntarily Recalled Products:

​Lannett Company, Inc. Voluntarily Recalled Ranitidine Syrup (oral solution) 15mg/mL:

Novitium Pharma Voluntarily Recalled Products:

Amneal Pharmaceuticals, LLC. Voluntarily Recalled Products:

Aurobindo Pharma USA, Inc. Voluntarily Recalled Products:

NATPARA® (parathyroid hormone) for Injection

Affected NDCs

What do you need to do?

For more information

CHOOSE YOUR PLAN TYPE

Lannett Company, Inc. Voluntarily Recalled Ranitidine Syrup (oral solution) 15mg/mL: