Histamine-1 Receptor Antagonist
Where is Desloratadine made?
10 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 5 factories in India and the United States.
India 4United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Belcher Pharmaceuticals,LLC5 mg · NDC 62250-619 | Belcher Pharmaceuticals, LLCMakes it and tests it | Location not on file | Not inspected on record |
| Caraco Pharmaceutical Laboratories, Ltd.5 mg · NDC 62756-523 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Dr.Reddy's Laboratories Ltd.2.5 mg, 5 mg · NDC 55111-551, 55111-360 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Lupin Pharmaceuticals, Inc.5 mg · NDC 68180-153 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Morepen Bio Inc.5 mg · NDC 87717-001 | Ajenat Pharmaceuticals LLCMakes it, tests it, packages it and labels it | Largo, FL, United States | No problems foundFeb 2025 |
| Natco Pharma USA LLC5 mg · NDC 69339-194 | Natco Pharma LimitedMakes it | Anakapalli, India | Problems found, fixed voluntarilyFeb 2023 |
| Virtus Pharmaceuticals, LLC5 mg · NDC 69543-107 | Ajenat Pharmaceuticals LLCMakes it and tests it | Largo, FL, United States | No problems foundFeb 2025 |
| Bionpharma Inc.5 mg · NDC 69452-363 | The label doesn't name the factory. Plants this company names for other drugs | ||
| INA Pharmaceutics Inc.0.5 mg per 1 mL · NDC 74157-011 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Organon LLC Clarinex5 mg · NDC 78206-119, 78206-188 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Desloratadine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-0765,50090-3975,50090-4794,50090-6724 - Bryant Ranch Prepack:
72162-2308,71335-1000 - Physicians Total Care, Inc.:
54868-4624 - Rebel Distributors Corp..:
21695-815
Recalls
- Dec 20, 2023 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.