Lupin Desloratadine 5mg Tablets Recall: N-Nitroso Impurity Risk
Lupin Pharmaceuticals recalls 5mg desloratadine tablets (NDC 68180-153-01/02) due to N-Nitroso desloratadine impurity exceeding safe limits. Rx-only products with specific lot numbers and expiration dates.
Lower-risk recall
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
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What happened, in plain English
Lupin Pharmaceuticals is recalling 5mg desloratadine tablets that may contain an impurity exceeding safe limits. This could pose a health risk with long-term use, though the risk is not immediately dangerous. Read more at govinfonow.com/recall/32923-lupin-desloratadine-5mg-tablets-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32923-lupin-desloratadine-5mg-tablets-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0221-2024
Cite this page
“Lupin Desloratadine 5mg Tablets Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32923-lupin-desloratadine-5mg-tablets-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0221-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0221-2024%22&limit=1).
Why it’s dangerous
The tablets contain an impurity called N-Nitroso desloratadine that exceeds the acceptable intake limit. This impurity could potentially cause health issues with long-term use, but the risk is not immediate or severe.
Who’s affected
Prescription owners of Lupin's 5mg desloratadine tablets (NDC 68180-153-01 or 02) with specific lot numbers and expiration dates. People taking this medication for allergies are most at risk.
How to tell if you have this one
Check for the product name 'Desloratadine Tablets USP 5mg' with NDC codes 68180-153-01 (100 count) or 68180-153-02 (500 count). The lot numbers are G201822, G201823, or G201824, all expiring in January 2024.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the NDC code and lot number on the bottle to confirm if it's part of the recall.
Contact Your Pharmacist
Ask your pharmacist if you have the recalled tablets and how to safely dispose of them.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0221-2024 (December 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0221-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.