The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0129-2020·Announced 2019-10-16

Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection

Sandoz is recalling Ranitidine Hydrochloride Capsules 300mg because a trace amount of the impurity NDMA was detected.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant chemical impurities like NDMA.

Plain-English summary

Sandoz, Inc. is recalling Sandoz Ranitidine Hydrochloride Capsules 300mg (NDC 0781-2865-31). The recall involves 136,788 bottles distributed nationwide in the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). The affected lots have expiration dates ranging from April 30, 2020, to March 31, 2021.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.

The recalled product

Product
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
Manufacturer
Sandoz, Inc
Category
Drug — Prescription Medication
Hazard
Affected units
136,788

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Sandoz, Inc 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 3 products in this recall →

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