Novitium Pharma LLC recalls Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive,
Novitium Pharma recalls 150 mg ranitidine capsules due to NDMA impurity detected in product. This may pose health risks. Consumers should check their prescription bottles for the NDC 70954-001-40.
Recall notice
CGMP Deviations: Presence of NDMA impurity detected in product.
Contact the company & request your remedy
What happened, in plain English
Novitium Pharma is recalling 150 mg ranitidine capsules (500 capsules per bottle) because they contain NDMA impurities. This could pose health risks, especially for people with certain health conditions or taking other medications. Read more at govinfonow.com/recall/37777-novitium-pharma-ranitidine-capsules-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37777-novitium-pharma-ranitidine-capsules-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0311-2020
Cite this page
“Novitium Pharma Ranitidine Capsules Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37777-novitium-pharma-ranitidine-capsules-recall-ndma-impurity-risk. Based on FDA recall #D-0311-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0311-2020%22&limit=1).
Why it’s dangerous
NDMA is a potential carcinogen that can form in some medications. The presence of this impurity in ranitidine capsules may increase cancer risk over time, especially with long-term use.
Who’s affected
Prescription holders of Novitium Pharma ranitidine capsules (150 mg, 500 capsules) are affected. People with kidney issues or taking other medications may be at higher risk.
How to tell if you have this one
Check your prescription bottle for the product name 'Ranitidine Capsules 150 mg 500 capsules' and the NDC number 70954-001-40. All lots within the expiration date are included in this recall.
- Brand
Novitium Pharma- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0310-2020 | Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20; all lots within expiry. | 19560 bottles |
| D-0311-2020 | 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; all lots within expiry. | 2718 bottles |
| D-0312-2020 | Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10; all lots within expiry. | 12312 bottles |
| D-0313-2020 | Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40; all lots within expiry. | 6660 bottles |
What to do — step by step
Check Product Details
Look for the NDC number 70954-001-40 on your prescription bottle.
Questions people ask
Is this product safe to take?
The recall states NDMA impurities were detected, but the product is not safe for long-term use. Consult your doctor if you have concerns.
How can I get a refund or replacement?
The recall record does not mention refunds or replacements. Contact Novitium Pharma directly for assistance.
Are there any specific health conditions that make this product more dangerous?
The recall record does not specify which health conditions increase risk. Consult your doctor for personalized advice.
Contact Novitium Pharma
We’ve drafted a message you can send Novitium Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0311-2020 — Novitium Pharma Novitium Pharma Hello, I own a Novitium Pharma that is covered by recall D-0311-2020 from Novitium Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0311-2020 (October 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0311-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.