Nonsteroidal Anti-inflammatory Drug, Prostaglandin E1 Analog
Where is Diclofenac and Misoprostol made?
8 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 4 factories in the United States and India.
United States 2India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals50 mg / 200 ug, 75 mg / 200 ug · NDC 65162-436, 65162-438 | Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | No problems foundApr 2026 |
| BluePoint Laboratories.50 mg / 200 ug, 75 mg / 200 ug · NDC 68001-231, 68001-232 | Actavis Laboratories FL, Inc.Makes it, tests it and packages it | Davie, FL, United States | Problems found, fixed voluntarilyNov 2025 |
| Eagle Pharmaceuticals, Inc.50 mg / 0.2 mg, 75 mg / 0.2 mg · NDC 42367-110, 42367-111 | Cipla LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyJun 2024 |
| Micro Labs Limited50 mg / 200 ug, 75 mg / 200 ug · NDC 42571-133, 42571-134 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Actavis Pharma, Inc.50 mg / 200 ug, 75 mg / 200 ug · NDC 0591-0397, 0591-0398 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.50 mg / 200 ug, 75 mg / 200 ug · NDC 59762-0028, 59762-0029 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nivagen Pharmaceuticals, Inc.50 mg / 200 ug, 75 mg / 200 ug · NDC 75834-264, 75834-265 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc Arthrotec50 mg / 200 ug, 75 mg / 200 ug · NDC 0025-1411, 0025-1421 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Diclofenac and Misoprostol 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:
50090-4618 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0272,80425-0273 - AvKARE, Inc.:
42291-232,42291-233 - Blenheim Pharmacal, Inc.:
10544-955,10544-949 - Bryant Ranch Prepack:
72162-2518,71335-1183,71335-2603,72162-2519+1 - Direct Rx:
61919-094 - Physicians Total Care, Inc.:
54868-4164,54868-4165 - Proficient Rx LP:
71205-865,71205-866 - Rebel Distributors Corp..:
21695-425 - Sportpharm LLC:
85766-192 - Stat Rx USA:
16590-024
Recalls
- Apr 20, 2018 · Class II · Exela Pharma Sciences LLC
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. - Sep 26, 2014 · Class II · Actavis Laboratories, FL, Inc.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets. - Apr 24, 2014 · Class II · Actavis Laboratories, FL, Inc. · 2 recall notices
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. - Dec 20, 2013 · Class II · Watson Laboratories, Inc.-(Actavis) - Florida
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. - Mar 22, 2013 · Class II · Actavis Inc
Failed Tablet/Capsule Specifications: Broken tablets - Mar 22, 2013 · Class II · Watson Laboratories, Inc.-(Actavis) - Florida
Failed Tablet/Capsule Specifications: Broken tablets - Sep 19, 2011 · Class II · Physicians Total Care, Inc.
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.