Agency classClass IIOur severity:Severe FDA (Drugs)·D-0639-2020·Announced 2020-01-15

Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because the product contains 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, and the rubric specifies that FDA Class II recalls with significant injury reports or structural defects are Severe; while no injuries are explicitly reported, the presence of NDMA in a Class II drug recall aligns with the Severe criteria for significant risk.

Plain-English summary

Glenmark Pharmaceuticals Inc. is recalling Glenmark Ranitidine Tablets USP 150 mg, 60-count bottles. The recall involves 208,668 bottles of the medication, which is distributed nationwide.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The affected lots are identified by the following codes: 7701164A, 7701471A, 7701670B, 7701827A, 7702242A, 7702705A, 7702947A, 7703408A, 7704494A, 7704495A, 19190289, 19190342, 19190372, and 7702737A.

Consumers and healthcare providers should check their inventory for these specific lot codes. The source text does not provide specific instructions for disposal or return, but patients should consult their healthcare provider regarding alternative treatments.

The recalled product

Product: Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Category: Drug — Prescription Medication
Hazard: ndma-impurity
Affected units: 208,668

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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