The Recall Desk
SevereFDA (Drugs)·D-0128-2020·Announced 2019-10-16

Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection

Sandoz is recalling 13,130 bottles of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe; while no injuries are explicitly reported here, the presence of a known carcinogenic impurity (NDMA) in a Class II drug recall aligns with the Severe tier for significant potential harm.

Plain-English summary

Sandoz, Inc. is recalling 13,130 bottles of Sandoz Ranitidine Hydrochloride Capsules 150mg (NDC 0781-2855-05). The product is distributed nationwide in the United States. The specific lots affected are identified by the codes HD1862 (expiration 4/30/2020), HP9438 (expiration 9/30/2020), HP9439 (expiration 9/30/2020), and HP9440 (expiration 9/30/2020).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), was detected in the product. The agency has classified this recall as Class II.

Consumers who have these specific bottles of Ranitidine Hydrochloride Capsules should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot codes and expiration dates listed above.

The recalled product

Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Manufacturer
Sandoz, Inc
Category
Drug — Prescription Medication
Hazard
Affected units
13,130

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020

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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