Central Nervous System Stimulant
Where is Amphetamine and Dextroamphetamine made?
27 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 18 factories in the United States.
United States 18
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Prasco Laboratories4 ingredients · NDC 66993-594, 66993-595, 66993-596 +3 | Cambrex Charles City, IncMakes the active ingredient | Charles City, IA, United States | Problems found, fixed voluntarilyMar 2025 |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Greenville, NC, United States | No problems foundSep 2025 | |
| Unither Manufacturing LLCMakes it and tests it | Rochester, NY, United States | Serious problems, FDA actionMay 2026 | |
| Sandoz Inc.4 ingredients · NDC 0781-2329, 0781-2335, 0781-2343 +9 | Cambrex Charles City, IncMakes the active ingredient | Charles City, IA, United States | Problems found, fixed voluntarilyMar 2025 |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Greenville, NC, United States | No problems foundSep 2025 | |
| Unither Manufacturing LLCMakes it and tests it | Rochester, NY, United States | Serious problems, FDA actionMay 2026 | |
| Takeda Pharmaceuticals America, Inc. Mydayis, AdderallXR4 ingredients · NDC 54092-468, 54092-471, 54092-474 +7 | Cambrex Charles City, IncMakes the active ingredient and tests it | Charles City, IA, United States | Problems found, fixed voluntarilyMar 2025 |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Greenville, NC, United States | No problems foundSep 2025 | |
| Unither Manufacturing LLCMakes it and tests it | Rochester, NY, United States | Serious problems, FDA actionMay 2026 | |
| Caraco Pharmaceutical Laboratories, Ltd.4 ingredients · NDC 57664-641, 57664-642, 57664-643 +8 | Frontida BioPharm, LLCMakes it | Philadelphia, PA, United States | No problems foundApr 2026 |
| Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 | |
| Global Pharmaceuticals, Division of Impax Laboratories Inc.4 ingredients · NDC 0115-1328, 0115-1329, 0115-1330 +3 | Cambrex Charles City, IncMakes the active ingredient, tests it and packages it | Charles City, IA, United States | Problems found, fixed voluntarilyMar 2025 |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Greenville, NC, United States | No problems foundSep 2025 | |
| Northstar Rx LLC.4 ingredients · NDC 16714-802, 16714-803, 16714-804 +10 | Aurolife Pharma LLCMakes it, tests it, packages it and labels it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Frontida BioPharm, LLCMakes it | Philadelphia, PA, United States | No problems foundApr 2026 | |
| SpecGx LLC4 ingredients · NDC 0406-8891, 0406-8884, 0406-8892 +13 | SpecGx LLCMakes it and tests it | Hobart, NY, United States | No problems foundMar 2020 |
| SpecGx LLCMakes the active ingredient | St. Louis, MO, United States | Problems found, fixed voluntarilyOct 2025 | |
| Accord Healthcare Inc.4 ingredients · NDC 16729-534, 16729-535, 16729-536 +4 | Wes Pharma IncMakes it and tests it | Westminster, MD, United States | Problems found, fixed voluntarilyNov 2025 |
| Alvogen Inc.4 ingredients · NDC 47781-174, 47781-175, 47781-176 +4 | Norwich Pharmaceuticals, Inc.Makes it, tests it and packages it | Norwich, NY, United States | No problems foundMay 2026 |
| Amneal Pharmaceuticals4 ingredients · NDC 0115-1486, 0115-1487, 0115-1488 +3 | Catalent Pharma Solutions, LLCMakes it and tests it | Winchester, KY, United States | Problems found, fixed voluntarilyApr 2025 |
| Ascent Pharmaceuticals, Inc.4 ingredients · NDC 43602-370, 43602-371, 43602-372 +17 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Aurolife Pharma LLC4 ingredients · NDC 13107-068, 13107-069, 13107-070 +4 | Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Burel Pharmaceuticals, LLC4 ingredients · NDC 35573-464, 35573-465, 35573-466 +3 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Camber Pharmaceuticals Inc.4 ingredients · NDC 31722-155, 31722-156, 31722-157 +10 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Elite Laboratories, Inc.4 ingredients · NDC 64850-510, 64850-511, 64850-512 +10 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Epic Pharma, LLC4 ingredients · NDC 42806-339, 42806-341, 42806-343 +2 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Golden State Medical Supply, Inc.4 ingredients · NDC 51407-558, 51407-557, 51407-559 +3 | Lannett Company, LLCMakes it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Granules Pharmaceuticals Inc.4 ingredients · NDC 70010-029, 70010-030, 70010-031 +10 | Granules Pharmaceuticals Inc.Makes it, tests it, packages it and labels it | Chantilly, VA, United States | Problems found, fixed voluntarilyApr 2026 |
| Rhodes Pharmaceuticals L.P.4 ingredients · NDC 42858-721, 42858-722, 42858-723 +10 | Knoa Pharmaceuticals LLCMakes it | Wilson, NC, United States | Problems found, fixed voluntarilySep 2025 |
| Sunrise Pharmaceutical, Inc.4 ingredients · NDC 11534-190, 11534-191, 11534-192 +4 | Sunrise Pharmaceutical IncMakes it, tests it and labels it | Rahway, NJ, United States | Problems found, fixed voluntarilyMar 2026 |
| Zydus Pharmaceuticals (USA) Inc.4 ingredients · NDC 68382-950, 68382-951, 68382-952 +10 | Nesher Pharmaceuticals (USA) LLCMakes it and tests it | Location not on file | Not inspected on record |
| ANI Pharmaceuticals, Inc.4 ingredients · NDC 43975-277, 43975-278, 43975-279 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Actavis Pharma, Inc.4 ingredients · NDC 0228-3062, 0228-3059, 0228-3063 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.4 ingredients · NDC 0527-0790, 0527-0791, 0527-0792 +10 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Oryza Pharmaceuticals Inc.4 ingredients · NDC 72516-016, 72516-015, 72516-014 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.4 ingredients · NDC 0555-0971, 0555-0775, 0555-0972 +11 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.4 ingredients · NDC 0480-3683, 0480-3684, 0480-3685 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Amphetamine and Dextroamphetamine 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.
- Bryant Ranch Prepack:
72162-1236,72162-1235,72162-2251,71335-0171+14 - Physicians Total Care, Inc.:
54868-6033,54868-6028,54868-6029,54868-6034+13 - Stat Rx USA:
16590-901
Recalls
- Jun 26, 2026 · Class II · Lannett Company Inc.
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. - Aug 28, 2025 · Class III · Granules Pharmaceuticals Inc. · 5 recall notices
Failed Impurities/Degradation Specifications: - Aug 19, 2025 · Class II · Lannett Company Inc.
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine A… - Aug 29, 2022 · Class II · Teva Pharmaceuticals USA Inc
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product. - Oct 9, 2020 · Class III · ANI Pharmaceuticals, Inc. · 6 recall notices
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - May 22, 2020 · Class II · Teva Pharmaceuticals USA · 3 recall notices
Some bottles may contain mixed strengths of the product. - Sep 19, 2019 · Class II · Aurobindo Pharma USA Inc.
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. - Nov 12, 2015 · Class II · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing. - Jun 24, 2015 · Class II · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification for unknown impurity - Oct 8, 2014 · Class II · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. - Jan 24, 2014 · Class II · Teva Pharmaceuticals USA
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadeq… - Feb 13, 2013 · Class III · Actavis Elizabeth LLC
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.