Ranitidine Syrup (Amneal) – 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
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Brand
Amneal Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Products Sold
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Amneal Pharmaceuticals, Inc. is recalling Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. 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 noticePage updated: Jan 7, 2026