Ranitidine 150mg (AVKARE) – 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
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Brand
AVKARE Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot 17708 Exp.11/30/2019 Lot 18459 Exp.03/31/2020 Lot 19033 Exp.07/31/2020 Lot 19032 Exp.07/31/2020 Lot 19031 Exp.06/30/2020 Lot 20204 Exp.09/30/2020 Lot 20205 Exp.09/30/2020 Lot 20663 Exp.10/31/2020 Lot 20664 Exp.11/30/2020 Lot 20665 Exp.11/30/2020 Lot 20666 Exp.11/30/2020 Lot 21039 Exp.12/31/2020 Lot 21920 Exp.04/30/2021
AVKARE Inc. is recalling AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 3422917355 due to CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. 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: Impurity N-nitrosodimethylamine (NDMA) found in API
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
CO, MO
Page updated: Jan 7, 2026