Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Yes — there is an active recall. 18 ongoing FDA recalls mention Ranitidine (100 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ranitidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Failed Stability Specifications
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Lack of sterility assurance.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Failed Impurity/Degradation Specification; "Related Compound C"
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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