Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products


                

Description Lot Number  Exp Date NDC
Ranitidine Capsules 150mg, 500 C606932 09/30/2019 55111012905
Ranitidine Capsules 150mg, 500 C606933 09/30/2019 55111012905
Ranitidine Capsules 150mg, 500 C607361 10/31/2019 55111012905
Ranitidine Capsules 150mg, 500 C607362 10/31/2019 55111012905
Ranitidine Capsules 150mg, 500 C607676 10/31/2019 55111012905
Ranitidine Capsules 150mg, 500 C607677 10/31/2019 55111012905
Ranitidine Capsules 150mg, 500 C608621 11/30/2019 55111012905
Ranitidine Capsules 150mg, 500 C608622 11/30/2019 55111012905
Ranitidine Capsules 150mg, 500 C700107 12/31/2019 55111012905
Ranitidine Capsules 150mg, 500 C700108 12/31/2019 55111012905
Ranitidine Capsules 150mg, 500 C700499 03/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C700500 03/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C701480 02/29/2020 55111012905
Ranitidine Capsules 150mg, 500 C701482 02/29/2020 55111012905
Ranitidine Capsules 150mg, 500 C702033 03/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C702034 03/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C702934 05/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C702935 05/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C703535 06/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C703866 07/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C703867 07/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C703869 07/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C704721 08/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C704722 08/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C705175 09/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C705176 09/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C705177 09/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C705178 09/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C706112 10/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C706113 10/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C706540 11/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C706541 11/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C706542 11/30/2020 55111012905
Ranitidine Capsules 150mg, 500 C800063 12/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C800066 12/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C800069 12/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C800070 12/31/2020 55111012905
Ranitidine Capsules 150mg, 500 C801115 01/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C801116 01/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C801117 01/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C801118 01/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C801742 02/28/2021 55111012905
Ranitidine Capsules 150mg, 500 C804068 04/30/2021 55111012905
Ranitidine Capsules 150mg, 500 C804069 05/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C804070 05/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C804071 05/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C804072 05/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C804073 05/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C805257 07/31/2021 55111012905
Ranitidine Capsules 150mg, 500 C805711 06/30/2021 55111012905
Ranitidine Capsules 150mg, 500 C807419 09/30/2021 55111012905
Ranitidine Capsules 150mg, 500 C807420 09/30/2021 55111012905
Ranitidine Capsules 150mg, 500 C807421 09/30/2021 55111012905
Ranitidine Capsules 150mg, 500 C807422 09/30/2021 55111012905
Ranitidine Capsules 150mg, 500 C902222 03/31/2022 55111012905
Ranitidine Capsules 150mg, 60 C606792 09/30/2019 55111012960
Ranitidine Capsules 150mg, 60 C606793 09/30/2019 55111012960
Ranitidine Capsules 150mg, 60 C606794 09/30/2019 55111012960
Ranitidine Capsules 150mg, 60 C606931 09/30/2019 55111012960
Ranitidine Capsules 150mg, 60 C607674 10/31/2019 55111012960
Ranitidine Capsules 150mg, 60 C607675 10/31/2019 55111012960
Ranitidine Capsules 150mg, 60 C700105 12/31/2019 55111012960
Ranitidine Capsules 150mg, 60 C700106 12/31/2019 55111012960
Ranitidine Capsules 150mg, 60 C700498 02/29/2020 55111012960
Ranitidine Capsules 150mg, 60 C701479 02/29/2020 55111012960
Ranitidine Capsules 150mg, 60 C701481 02/29/2020 55111012960
Ranitidine Capsules 150mg, 60 C702035 03/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C702932 05/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C702933 05/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C703534 06/30/2020 55111012960
Ranitidine Capsules 150mg, 60 C703868 07/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C705179 09/30/2020 55111012960
Ranitidine Capsules 150mg, 60 C705180 09/30/2020 55111012960
Ranitidine Capsules 150mg, 60 C705181 09/30/2020 55111012960
Ranitidine Capsules 150mg, 60 C705906 10/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C705907 10/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C706114 10/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C706115 11/30/2020 55111012960
Ranitidine Capsules 150mg, 60 C706543 11/30/2020 55111012960
Ranitidine Capsules 150mg, 60 C800064 12/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C800065 12/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C800067 12/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C800068 12/31/2020 55111012960
Ranitidine Capsules 150mg, 60 C801113 01/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C801114 01/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C801741 02/28/2021 55111012960
Ranitidine Capsules 150mg, 60 C801743 02/28/2021 55111012960
Ranitidine Capsules 150mg, 60 C801744 04/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C803381 05/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C803382 05/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C803383 05/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C805712 06/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C805713 06/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C805714 06/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C805715 06/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C805716 06/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C805717 07/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C807423 09/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C807424 09/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C807425 09/30/2021 55111012960
Ranitidine Capsules 150mg, 60 C900168 12/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C900169 12/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C900170 12/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C900171 12/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C900248 12/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C900249 12/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C900250 12/31/2021 55111012960
Ranitidine Capsules 150mg, 60 C901480 01/31/2022 55111012960
Ranitidine Capsules 150mg, 60 C901481 01/31/2022 55111012960
Ranitidine Capsules 150mg, 60 C902221 03/31/2022 55111012960
Ranitidine Capsules 300mg, 100 C607363 09/30/2019 55111013001
Ranitidine Capsules 300mg, 100 C700104 01/31/2020 55111013001
Ranitidine Capsules 300mg, 100 C700891 01/31/2020 55111013001
Ranitidine Capsules 300mg, 100 C701485 02/29/2020 55111013001
Ranitidine Capsules 300mg, 100 C702031 03/31/2020 55111013001
Ranitidine Capsules 300mg, 100 C703536 06/30/2020 55111013001
Ranitidine Capsules 300mg, 100 C705182 09/30/2020 55111013001
Ranitidine Capsules 300mg, 100 C705909 10/31/2020 55111013001
Ranitidine Capsules 300mg, 100 C706547 11/30/2020 55111013001
Ranitidine Capsules 300mg, 100 C803384 05/31/2021 55111013001
Ranitidine Capsules 300mg, 30 C606934 09/30/2019 55111013030
Ranitidine Capsules 300mg, 30 C606935 10/31/2019 55111013030
Ranitidine Capsules 300mg, 30 C606936 10/31/2019 55111013030
Ranitidine Capsules 300mg, 30 C607364 09/30/2019 55111013030
Ranitidine Capsules 300mg, 30 C608618 11/30/2019 55111013030
Ranitidine Capsules 300mg, 30 C608619 11/30/2019 55111013030
Ranitidine Capsules 300mg, 30 C700102 12/31/2019 55111013030
Ranitidine Capsules 300mg, 30 C700103 12/31/2019 55111013030
Ranitidine Capsules 300mg, 30 C701483 02/29/2020 55111013030
Ranitidine Capsules 300mg, 30 C701484 02/29/2020 55111013030
Ranitidine Capsules 300mg, 30 C702032 03/31/2020 55111013030
Ranitidine Capsules 300mg, 30 C702355 04/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C702356 04/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C703537 06/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C704070 07/31/2020 55111013030
Ranitidine Capsules 300mg, 30 C704071 07/31/2020 55111013030
Ranitidine Capsules 300mg, 30 C704723 08/31/2020 55111013030
Ranitidine Capsules 300mg, 30 C704724 08/31/2020 55111013030
Ranitidine Capsules 300mg, 30 C705183 09/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C705184 09/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C705185 09/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C705908 10/31/2020 55111013030
Ranitidine Capsules 300mg, 30 C706544 11/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C706545 11/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C706546 11/30/2020 55111013030
Ranitidine Capsules 300mg, 30 C800071 01/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C800072 01/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C800073 01/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C800074 01/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C800075 02/28/2021 55111013030
Ranitidine Capsules 300mg, 30 C800076 02/28/2021 55111013030
Ranitidine Capsules 300mg, 30 C800077 02/28/2021 55111013030
Ranitidine Capsules 300mg, 30 C801119 02/28/2021 55111013030
Ranitidine Capsules 300mg, 30 C801745 02/28/2021 55111013030
Ranitidine Capsules 300mg, 30 C803385 05/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C803386 05/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C805258 06/30/2021 55111013030
Ranitidine Capsules 300mg, 30 C805259 06/30/2021 55111013030
Ranitidine Capsules 300mg, 30 C805260 06/30/2021 55111013030
Ranitidine Capsules 300mg, 30 C805261 06/30/2021 55111013030
Ranitidine Capsules 300mg, 30 C805262 06/30/2021 55111013030
Ranitidine Capsules 300mg, 30 C805263 07/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C805264 07/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C805265 07/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C805718 07/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C805719 07/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C805720 07/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C809503 11/30/2021 55111013030
Ranitidine Capsules 300mg, 30 C900251 12/31/2021 55111013030
Ranitidine Capsules 300mg, 30 C900252 01/31/2022 55111013030
Ranitidine Capsules 300mg, 30 C901479 01/31/2022 55111013030
Ranitidine Capsules 300mg, 30 C902223 03/31/2022 55111013030
Ranitidine Capsules 300mg, 30 C902224 03/31/2022 55111013030

Dr. Reddy's is voluntarily recalling the above items/lots due to USFDA alert notice regarding low levels of N-nitrosodimethylamine (NDMA) impurity found in some samples of Ranitidine medicines, subsequent preliminary test results at Dr. Reddy's laboratories for some for the Drug Substance (API) lots used in Drug Product manufacturing have levels of NDMA that could potentially contribute to elevated levels of NDMA in Drug Product with respect to the maximum allowable daily limit. Affected product started shipping January 2017.

If consumers have questions regarding this recall or to report an adverse event, please contact the Company's Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday.

Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality concerns experienced with the use of this product may also 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.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Contact:

Medical Information: Dr.Reddy's Call Center 888-375-3784