Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Ranitidine recalled?

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.

Ranitidine recalls on record

none so far in 2026; 100 on record, newest first
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Completed Nitrosamine impurity Dr. Reddy's Laboratories, Inc. NDC 69842-871-30 D-0173-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Completed Nitrosamine impurity Dr. Reddy's Laboratories, Inc. NDC 30142-505-34 D-0172-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Completed Nitrosamine impurity Dr. Reddy's Laboratories, Inc. NDC 49035-404-61 D-0171-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Completed Nitrosamine impurity Dr. Reddy's Laboratories, Inc. NDC 0363-0010-34 D-0170-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Completed Nitrosamine impurity Dr. Reddy's Laboratories, Inc. D-0169-2020
Class III · Low risk

Ranitidine Tablets USP

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Ongoing cGMP deviation AuroMedics Pharma LLC NDC 55910-092-79 D-0166-2020
Class III · Low risk

Ranitidine Syrup

Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

Terminated Impurity / degradation Bio-pharm, Inc. NDC 23155-291-51 D-0809-2016
Class III · Low risk

Ranitidine Syrup

Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

Terminated Stability / shelf life Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals D-0162-2016
Class II · Moderate risk

Ranitidine HCl active pharmaceutical ingredient packaged in…

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.

Terminated Cross-contamination Attix Pharmaceuticals D-875-2015
Class II · Moderate risk

Ranitidine Tablets USP

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.

Terminated Particulate / foreign matter Glenmark Generics Inc., USA NDC 68462-248-05 D-1229-2014
Class II · Moderate risk

Ranitidine Hydrochloride Tablets

Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.

Terminated Microbial contamination Dr. Reddy's Laboratories, Inc. NDC 49035-404-61 D-884-2013
Class II · Moderate risk

Ranitidine Syrup

Failed Impurity/Degradation Specification; "Related Compound C"

Terminated Impurity / degradation Actavis South Atlantic LLC D-829-2013
Class II · Moderate risk

Ranitidine 25mg/Ml Injectable 200 Ml 480 Ml 800 Ml

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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1612-2012