NDC 0904-2725
Sulfamethoxazole and Trimethoprim 160 mg / 800 mg tablet
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Amneal Pharmaceuticals's NDC 65162-272.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals Private Limited | Ahmedabad, India | Makes it, tests it, packages it and labels it | No problems foundJul 19, 2024 · 6 inspections |
Recalls
- Sep 2, 2025 · Class II · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots: Lot # N02309, Exp 03/31/2027 - Sep 2, 2025 · Class II · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots: Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027 - Aug 18, 2025 · Class II · Amneal Pharmaceuticals, LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots: Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2… - Jun 2, 2025 · Class I · Amneal Pharmaceuticals, LLC
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Lots: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027 - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sulfamethoxazole and Trimethoprim: every company that makes it
- Form
- tablet, oral
- Strength
- 160 mg / 800 mg
- Approval
- ANDA ANDA076899
- On the market since
- Sep 13, 2010
- Package NDCs
0904-2725-61- Official label
- DailyMed (National Library of Medicine), updated Nov 18, 2025
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