Corticosteroid
Where is Betamethasone made?
28 companies sell it under their own name and 15 repackagers rebottle it. Their labels name 15 factories in India, the United States, Canada, Israel, Germany and Spain.
India 6United States 4Canada 2Israel 1Germany 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.5 mg per 1 g, 0.5 mg per 1 mL, 1 mg per 1 g, 1.2 mg per 1 g · NDC 51672-1274, 51672-1309, 51672-1390 +4 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 | |
| Alembic Pharmaceuticals Inc.1.2 mg per 1 g · NDC 62332-708 | Alembic Pharmaceuticals LimitedMakes it and tests it | Vadodara, India | No problems foundMar 2023 |
| Alembic Pharmaceuticals Limited1.2 mg per 1 g · NDC 46708-708 | Alembic Pharmaceuticals LimitedMakes it and tests it | Vadodara, India | No problems foundMar 2023 |
| American Regent, Inc.3 mg per 1 mL · NDC 0517-0720, 0517-0791, 0517-0799 | American Regent, Inc.Makes it | Hilliard, OH, United States | Problems found, fixed voluntarilyJun 2026 |
| Aurobindo Pharma Limited0.5 mg per 1 g · NDC 59651-699, 59651-891 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Burel Pharmaceuticals, LLC0.5 mg per 1 g · NDC 35573-107 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Cadila Healthcare Limited0.5 mg per 1 g · NDC 70771-1550, 70771-1380 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Cosette Pharmaceuticals, Inc. Betamethasone Valerate0.5 mg per 1 g, 0.5 mg per 1 mL, 1.2 mg per 1 g · NDC 0713-0659, 0713-0807, 0713-0326 +1 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| E. FOUGERA & CO., A division of Nycomed US Inc. Betamethasone Dipropionate, Betamethasone Valerate0.5 mg per 1 g, 0.5 mg per 1 mL, 1 mg per 1 g, 1 mg per 1 mL · NDC 0168-0268, 0168-0056, 0168-0055 +5 | Salutas Pharma GmbHMakes it | Sülzetal, Germany | Not inspected on record |
| Encube Ethicals, Inc.0.5 mg per 1 mL · NDC 21922-104 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Golden State Medical Supply, Inc.0.5 mg per 1 g · NDC 51407-273 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| H.J. Harkins Co., Inc.0.5 mg per 1 g · NDC 52959-262 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Lupin Pharmaceuticals, Inc.0.5 mg per 1 g · NDC 68180-947 | Lupin LimitedMakes it and packages it | Pithampur, India | Problems found, fixed voluntarilyJul 2025 |
| Northstar Rx LLC.0.5 mg per 1 g · NDC 16714-996 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Primus Pharmaceuticals, Inc. Sernivo0.5 mg per 1 g · NDC 68040-714 | Symbiotec Pharmalab LimitedMakes the active ingredient | Indore, India | Problems found, fixed voluntarilyApr 2026 |
| Teligent Pharma, Inc.0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 52565-019, 52565-023 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| TruPharma LLC.0.5 mg per 1 g · NDC 52817-824 | Halo Pharmaceutical Canada, IncMakes it, tests it, packages it and labels it | Mirabel, Canada | No problems foundFeb 2023 |
| Viona Pharmaceuticals Inc.0.5 mg per 1 g · NDC 72578-093 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Xiromed, LLC.1.2 mg per 1 g · NDC 70700-141 | Laboratorios Liconsa SAUMakes it | Azuqueca De Henares, Spain | Problems found, fixed voluntarilyJan 2025 |
| Zydus Pharmaceuticals (USA) Inc.0.5 mg per 1 g · NDC 70710-1233 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Actavis Pharma, Inc.0.5 mg per 1 g · NDC 0472-0380, 0472-0381, 0472-0382 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Asclemed USA, Inc.3 mg per 1 mL · NDC 76420-240 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Thrower's Skincare, Inc.0.05 g per 100 g · NDC 69299-202, 69299-201 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Oaklock, LLC3 mg per 1 mL · NDC 69263-822 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Organon LLC Diprolene, Celestone Soluspan0.5 mg per 1 g, 3 mg per 1 mL · NDC 78206-124, 78206-118 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd0.5 mg per 1 g, 1.2 mg per 1 g · NDC 45802-021, 45802-376, 45802-505 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories0.5 mg per 1 g · NDC 66993-897 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Stat Rx USA.64 mg per 1 g · NDC 16590-032 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Betamethasone 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:
50090-2091,50090-5260,50090-1192,50090-1839+13 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0347 - Asclemed USA, Inc.:
76420-858,76420-007 - Bryant Ranch Prepack:
63629-8614,63629-8613,63629-9323,63629-9324+3 - H.J. Harkins Co., Inc.:
52959-721,52959-124 - NuCare Pharmaceuticals.Inc.:
68071-2850,68071-4814,68071-4556,68071-4278+3 - Physicians Total Care, Inc.:
54868-6292,54868-0973,54868-3280,54868-5692+2 - Preferred Pharmaceuticals, Inc..:
68788-7670,68788-9219,68788-8450,68788-8496+1 - Proficient Rx LP:
63187-433,71205-275,71205-040,71205-364 - RPK Pharmaceuticals, Inc.:
53002-8280,53002-8281,53002-9211,53002-9210+1 - Rebel Distributors Corp..:
21695-614,21695-521,21695-584 - RedPharm Drug. Inc.:
67296-2275,67296-0573,67296-2080 - Remedyrepack Inc.:
70518-4187 - Sportpharm LLC:
85766-070 - Stat Rx USA:
16590-034
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Aug 23, 2021 · Class II · Teligent Pharma, Inc.
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing - Feb 2, 2021 · Class III · Teligent Pharma, Inc. · 2 recall notices
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. - May 20, 2019 · Class III · Teligent Pharma, Inc.
Failed Impurities/Degradation Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.