Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because of the presence of the NDMA impurity.
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, which corresponds to a Severe severity score under the rubric for significant health risks.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Glenmark Ranitidine Tablets USP 300 mg, Rx Only, 30 Tablets (NDC 68462-249-30). The recall involves 98,988 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. The affected lot codes are 7701429A, 7701522A, 7702255A, 7704745A, 19190456, 19190472, and 19190490.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 98,988
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)
- 7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
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 →Related recalls
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · ndma impurity
See all →- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets
FDA (Drugs) · 2021-05-26
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-02-10
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-01-20
- SevereDenton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereDirect Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
FDA (Drugs) · 2020-11-11