Amneal Pharmaceuticals recalls Ranitidine medication due to possible human carcinogen

Amneal Pharmaceuticals recalled Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup, 15 mg/mL due to a possible human carcinogen, according to the U.S. Food and Drug Administration.

Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests, according to the FDA.

Amneal Pharmaceuticals, LLC. has not received any reports of adverse events that have been confirmed to be directly related to this recall.

The Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) subject to the recall can be identified by NDC numbers stated on the product label:

Product

Strength

Pack Size

NDC Number

Ranitidine Tablets, USP 150 mg 60 count 65162-253-06
Ranitidine Tablets, USP 150 mg 100 count 65162-253-10
Ranitidine Tablets, USP 150 mg 180 count 65162-253-18
Ranitidine Tablets, USP 150 mg 500 count 65162-253-50
Ranitidine Tablets, USP 150 mg 1000 count 65162-253-11
Ranitidine Tablets, USP 300 mg 30 count 65162-254-03
Ranitidine Tablets, USP 300 mg 100 count 65162-254-10
Ranitidine Tablets, USP 300 mg 250 count 65162-254-25
Ranitidine Tablets, USP 300 mg 1000 count 65162-254-11
Ranitidine Tablets, USP 150 mg 500 count 53746-253-05
Ranitidine Tablets, USP 150 mg 1000 count 53746-253-10
Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL; 16 fl. oz. 473 mL 65162-664-90

Amneal will notify affected  customers via mail.

Customers who purchased the impacted product directly from Amneal can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) which are being recalled should stop using the product and can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The following lot numbers of Ranitidine Tablets, USP, 150 mg & 300 mg and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL are included in this recall.

Ranitidine Tablets, USP, 150 mg

Description

Lot#

Expiration Date

Ranitidine Tablets, USP 150mg

AR180483B

3/31/2020

Ranitidine Tablets, USP 150mg

AR180559A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180560A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180594A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180595A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180675A

4/30/2020

Ranitidine Tablets, USP 150mg

AR180829A

4/30/2020

Ranitidine Tablets, USP 150mg

AR180831A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180832A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180868A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180868B

5/31/2020

Ranitidine Tablets, USP 150mg

AR180869A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180870A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180871A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180872A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180995A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180996A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180997A

6/30/2020

Ranitidine Tablets, USP 150mg

AR180998A

6/30/2020

Ranitidine Tablets, USP 150mg

AR181158A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181159A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181160A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181161A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181690A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181691A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181692A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181693A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181694A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181709A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181710A

11/30/2020

Ranitidine Tablets, USP 150mg

AR181711A

11/30/2020

Ranitidine Tablets, USP 150mg

AR181806A

11/30/2020

Ranitidine Tablets, USP 150mg

AR181807B

11/30/2020

Ranitidine Tablets, USP 150mg

AR181807C

11/30/2020

Ranitidine Tablets, USP 150mg

AR181808A

11/30/2020

Ranitidine Tablets, USP 150mg

AR190004A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190005A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190006A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190007A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190008A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190008B

12/31/2020

Ranitidine Tablets, USP 150mg

AR190085A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190086A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190087A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190088A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190089A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190090A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190121A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190122A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190123A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190124A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190125B

1/31/2021

Ranitidine Tablets, USP 150mg

AR190181A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190182A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190183A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190184A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190364A

2/28/2021

Ranitidine Tablets, USP 150mg

AR190365A

2/28/2021

Ranitidine Tablets, USP 150mg

AR190366A

2/28/2021

Ranitidine Tablets, USP 150mg

AR190366B

2/28/2021

Ranitidine Tablets, USP 150mg

AR190509A

3/31/2021

Ranitidine Tablets, USP 150mg

AR190510A

3/31/2021

Ranitidine Tablets, USP 150mg

AR190542B

3/31/2021

Ranitidine Tablets, USP 150mg

AR190609A

3/31/2021

Ranitidine Tablets, USP 150mg

AR190610A

3/31/2021

Ranitidine Tablets, USP 150mg

HD03119A

3/31/2021

Ranitidine Tablets, USP 150mg

HD03219A

3/31/2021

Ranitidine Tablets, USP 150mg

HE03119A

4/30/2021

Ranitidine Tablets, USP 150mg

HE03219A

4/30/2021

Ranitidine Tablets, USP, 300 mg

Description

Lot#

Expiration Date

Ranitidine Tablets, USP 300mg

AR180519A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180613A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180615A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180638A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180640A

4/30/2020

Ranitidine Tablets, USP 300mg

AR180641A

4/30/2020

Ranitidine Tablets, USP 300mg

AR181156A

7/31/2020

Ranitidine Tablets, USP 300mg

AR181157A

7/31/2020

Ranitidine Tablets, USP 300mg

AR181795A

11/30/2020

Ranitidine Tablets, USP 300mg

AR181920A

12/31/2020

Ranitidine Tablets, USP 300mg

AR181921A

12/31/2020

Ranitidine Tablets, USP 300mg

AR181921B

12/31/2020

Ranitidine Tablets, USP 300mg

AR190414B

2/28/2021

Ranitidine Tablets, USP 300mg

AR190415A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190416A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190417A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190418A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190418B

2/28/2021

Ranitidine Tablets, USP 300mg

AR190543A

3/31/2021

Ranitidine Tablets, USP 300mg

AR190544A

3/31/2021

Ranitidine Tablets, USP 300mg

AR190545A

3/31/2021

Ranitidine Tablets, USP 300mg

AR190705A

4/30/2021

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

Description

Lot#

Expiration Date

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

06648001A

11/2019

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

06648003A

04/2020

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

06649001A

01/2021

Source: U.S. Food and Drug Administration

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