Agency classClass IIOur severity:Severe FDA (Drugs)·D-0644-2020·Announced 2020-01-15

Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because testing detected the presence of the NDMA impurity.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential health risks such as carcinogenic impurities.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Glenmark Ranitidine Tablets USP 150 mg, 500-count bottles (NDC 68462-248-05). The recall involves 1,712,632 bottles distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. NDMA is a potential carcinogen that is strictly regulated in pharmaceutical products.

Consumers who have purchased these specific bottles should stop using the medication and contact their healthcare provider for guidance on alternative treatments. The affected lot codes are listed in the official FDA recall notice D-0644-2020.

The recalled product

Product: Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Category: Drug — Prescription Medication
Hazard: ndma-impurity
carcinogen
Affected units: 1,712,632

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Glenmark Pharmaceuticals Inc., USA 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 6 products in this recall →

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

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