Prostaglandin E1 Analog
Where is Misoprostol made?
7 companies sell it under their own name and 18 repackagers rebottle it. Their labels name 1 factory in the United States.
United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Lupin Pharmaceuticals, Inc.100 ug, 200 ug · NDC 43386-160, 43386-161 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Novel Laboratories, Inc.100 ug, 200 ug · NDC 40032-160, 40032-161 | Novel Laboratories, Inc.Makes it and tests it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| ANI Pharmaceuticals, Inc.100 ug, 200 ug · NDC 70954-443, 70954-444 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvPAK200 ug · NDC 50268-555 | The label doesn't name the factory. Plants this company names for other drugs | ||
| GenBioPro, Inc.200 ug · NDC 43393-200 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.100 ug, 200 ug · NDC 59762-5007, 59762-5008 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc Cytotec100 ug, 200 ug · NDC 0025-1451, 0025-1461 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy 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.
- Aidarex Pharmaceuticals LLC:
33261-754,33261-076 - American Health Packaging:
60687-735,60687-746 - Apotheca, Inc.:
12634-933,12634-502 - Avera McKennan Hospital:
69189-0161 - Bryant Ranch Prepack:
63629-7929,71335-2455,71335-9631,71335-0460 - Cardinal Health 107, LLC:
55154-2145 - Dispensing Solutions Inc.:
66336-608 - GenBioPro, Inc.:
43393-203,43393-023,43393-024 - H.J. Harkins Co., Inc.:
52959-692 - Marlex Pharmaceuticals, Inc.:
10135-745,10135-746 - NuCare Pharmaceuticals.Inc.:
68071-3762,68071-2904,68071-3458,68071-4843 - PD-Rx Pharmaceuticals, Inc.:
72789-121,72789-300,43063-707 - PharmPak, Inc.:
54348-148 - Physicians Total Care, Inc.:
54868-2176 - Proficient Rx LP:
82804-037 - ReadyMeds:
64205-161 - RedPharm Drug. Inc.:
67296-1936 - Unit Dose Services:
50436-3172
Recalls
- Sep 9, 2016 · Class III · Pfizer Inc.
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.