Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
Novitium Pharma LLC is recalling 2,718 bottles of Ranitidine Capsules 150 mg because the product contains 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, and the presence of the NDMA impurity in a drug product represents a significant health risk that meets the criteria for a Severe rating.
Plain-English summary
Novitium Pharma LLC is recalling 2,718 bottles of Ranitidine Capsules 150 mg (NDC 70954-001-40). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.
The affected product is distributed nationwide. The recall covers all lots within the expiration date. The product is a prescription-only medication manufactured by Novitium Pharma LLC in East Windsor, New Jersey.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40
- Manufacturer
- Novitium Pharma LLC
- Category
- Drug — Prescription Medication
- Affected units
- 2,718
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)
- all lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Novitium Pharma LLC 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.
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