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.
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 and involves the detection of NDMA, a known carcinogenic impurity, which meets the rubric criteria for a Severe rating.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling Glenmark Ranitidine Tablets USP 300 mg, prescription only, 250 tablets per bottle. The recall involves 500,960 bottles distributed nationwide. The product is manufactured by Glenmark Pharmaceuticals Ltd. in India for Glenmark Pharmaceuticals Inc. in the USA.
The FDA identified the recall as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the presence of the NDMA impurity was detected in the product.
Consumers should stop using the recalled 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 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- Affected units
- 500,960
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