Recall archive / FDA company announcement
Amneal: Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg — FDA announcement Jun 4, 2025
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Jun 4, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg
- Reason
- Microbial contamination
- Classification
- Not supplied
- Recalling firm
- Amneal Pharmaceutical LLC
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 11f07257b7d4cd2f
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg is packaged in 100 tablet count and 500 tablet count bottles. This recall pertains only to the 400 mg/80 mg strength and only to the listed Lots below. The lot number can be found on the Amneal bottle label or consult your pharmacy if you received a pharmacy vial. No other Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg lots are impacted.; Lot Number | NDC Number | Expiration date | Date of First Distribution | Bottle Pack Size; AM241019 | 65162-271-10 | 06/2027 | 12/4/2024 | 100 count; AM241019A | 65162-271-50 | 06/2027 | 12/4/2024 | 500 count; AM241020 | 65162-271-10 | 06/2027 | 12/4/2024 | 100 count |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| Lot Number | NDC Number | Expiration date | Date of First Distribution | Bottle Pack Size |
|---|---|---|---|---|
| AM241019 | 65162-271-10 | 06/2027 | 12/4/2024 | 100 count |
| AM241019A | 65162-271-50 | 06/2027 | 12/4/2024 | 500 count |
| AM241020 | 65162-271-10 | 06/2027 | 12/4/2024 | 100 count |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
The recalled product was distributed nationwide to wholesalers/distributors between the dates of 12/4/2024 to 5/15/2025 only. The product is indicated for the treatment of Urinary tract infections caused by susceptible strains of the following organisms: Escherichia Coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. Acute otitis media in pediatric patients. Acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae. Enteritis caused by susceptible strains of Shigella flexneri and traveler's diarrhea in adults.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Jun 4, 2025
- Company announcement date
- Jun 2, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.