Ranitidine Capsules 300mg (Golden State Medical) – NDMA Impurity (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
Brand
Golden State Medical Supply Inc.
Lot Codes / Batch Numbers
Lot Codes: GS023971, Exp. 10/31/2020, GS025527, Exp. 10/31/2020, GS025526, Exp. 10/31/2020, GS026114, Exp. 10/31/2020, GS025813, Exp. 10/31/2020, GS026189, Exp. 10/31/2021, GS027555, Exp. 7/31/2021, GS026190, Exp. 5/31/2021, GS026220, Exp. 05/31/2021, GS026584, Exp. 05/31/2021, GS027139, Exp. 05/31/2021, GS027554, Exp. 05/31/2021.
Products Sold
Lot Codes: GS023971, Exp. 10/31/2020; GS025527, Exp. 10/31/2020; GS025526, Exp. 10/31/2020; GS026114, Exp. 10/31/2020; GS025813, Exp. 10/31/2020; GS026189, Exp. 10/31/2021; GS027555, Exp. 7/31/2021; GS026190, Exp. 5/31/2021; GS026220, Exp. 05/31/2021; GS026584, Exp. 05/31/2021; GS027139, Exp. 05/31/2021; GS027554, Exp. 05/31/2021.
Golden State Medical Supply Inc. is recalling GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novi due to CGMP Deviations: Presence of NDMA impurity detected in product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Presence of NDMA impurity detected in product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, IA, MA, MO
Page updated: Jan 7, 2026