Agency classClass IIOur severity:Severe FDA (Drugs)·D-0642-2020·Announced 2020-01-15

Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because the FDA detected the NDMA impurity 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 recall is classified as FDA Class II and involves the detection of NDMA, a known carcinogenic impurity, which meets the criteria for a Severe rating.

Plain-English summary

Glenmark Pharmaceuticals Inc. is recalling Glenmark Ranitidine Tablets USP 300 mg, 100-count bottles. The recall involves 1,309,536 bottles distributed nationwide.

The FDA identified the presence of the NDMA impurity in the product, which constitutes a Current Good Manufacturing Practice (CGMP) deviation. The agency has classified this recall as Class II.

Consumers should check their medication for the specific NDC 68462-249-01 and the lot codes listed in the recall notice. If the medication matches the recalled product, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product: Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Category: Drug — Prescription Medication
Hazard: ndma-impurity
Affected units: 1,309,536

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

See all →

Moderate
Azelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
Moderate
Alyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
Moderate
Ondansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
Critical
Frozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
Moderate
Bisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10

Same hazard · ndma impurity