Recent Voluntary Drug Recalls

Ranitidine Capsules, Tablets and Oral Solution

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.


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

Jul-20

59651-144-05

Jul-20

Jul-20

Aug-20

Aug-20

59651-144-60

Aug-20

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

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: