The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0530-2020·Announced 2019-12-04

Aurobindo Ranitidine Capsules Recalled for NDMA Contamination

AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the detection of a potential carcinogen (NDMA) in a prescription drug.

Plain-English summary

AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg, 500 count bottles, which are distributed by Aurobindo Pharma USA, Inc. The recall involves 26,736 bottles of the prescription-only medication, identified by NDC 59651-144-05. The affected lots were distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of N-nitrosodimethylamine (NDMA) in Ranitidine tablets, capsules, and syrups. The source text notes that NDMA has been detected in these forms of Ranitidine, prompting the specific recall of the Aurobindo capsules.

Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall covers specific lot codes and expiration dates ranging from July 2020 to May 2021, as listed in the product information.

The recalled product

Product
Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Prescription Medication
Hazard
Affected units
26,736

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by AuroMedics Pharma LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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