Anticholinergic, Antidiarrheal
Where is Atropine and Diphenoxylate made?
10 companies sell it under their own name and 21 repackagers rebottle it. Their labels name 6 factories in the United States.
United States 6
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Winder Laboratories, LLC2.5 mg / 0.025 mg · NDC 75826-107 | Winder Laboratories, LLCMakes it | Winder, GA, United States | Serious problems, FDA actionAug 2025 |
| Winder Laboratories, LLCMakes it | Winder, GA, United States | Serious problems, FDA actionAug 2025 | |
| Hikma Pharmaceuticals USA Inc.2.5 mg per 5 mL / 0.025 mg per 5 mL · NDC 0054-3194 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Leading Pharma, LLC2.5 mg / 0.025 mg · NDC 69315-910 | Leading Pharma, LLCMakes it, tests it and packages it | Fairfield, NJ, United States | Problems found, fixed voluntarilyOct 2024 |
| Neolpharma, Inc.2.5 mg / 0.025 mg · NDC 55466-783 | Neolpharma, Inc.Makes it, tests it, packages it and labels it | Caguas, PR, United States | Problems found, fixed voluntarilyMar 2026 |
| Unichem Pharmaceuticals (USA), Inc.2.5 mg / 0.025 mg · NDC 76385-107 | Cerovene, Inc.Makes it and tests it | Valley Cottage, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| ANI Pharmaceuticals, Inc.2.5 mg / 0.025 mg · NDC 62559-490 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.2.5 mg / 0.025 mg · NDC 62135-618 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.2.5 mg / 0.025 mg · NDC 59762-1061 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc Lomotil2.5 mg / 0.025 mg · NDC 0025-0061 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SpecGx LLC2.5 mg / 0.025 mg · NDC 0406-1236 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Atropine and Diphenoxylate 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:
50090-0040,50090-0039,50090-2872,50090-2641+3 - Aidarex Pharmaceuticals LLC:
33261-685 - American Health Packaging:
60687-890 - Aphena Pharma Solutions - Tennessee, Inc.:
67544-021,43353-083,43353-594,71610-714+1 - Apotheca, Inc.:
12634-531 - Atlantic Biologicals Corps.:
17856-1061,17856-3194 - Bryant Ranch Prepack:
71335-1693,71335-0311 - Direct Rx:
61919-080,72189-336 - Dispensing Solutions Inc.:
66336-437 - Lohxa:
70166-630 - NuCare Pharmaceuticals.Inc.:
68071-2328,68071-4063 - PD-Rx Pharmaceuticals, Inc.:
72789-375 - Physicians Total Care, Inc.:
54868-0427,54868-0032 - Preferred Pharmaceuticals, Inc..:
68788-8090 - Proficient Rx LP:
63187-939,71205-909 - RPK Pharmaceuticals, Inc.:
53002-3401,53002-3400 - Rebel Distributors Corp..:
21695-688 - RedPharm Drug Inc.:
67296-0505 - RedPharm Drug. Inc.:
67296-1572,67296-1675,67296-1210,67296-1241+2 - Remedyrepack Inc.:
70518-3915 - Stat Rx USA:
16590-080
Recalls
- Oct 20, 2017 · Class I · Pfizer Inc.
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.