Yes — there is an active recall. 6 ongoing FDA recalls mention Sulfamethoxazole (18 total). Check the affected lots below.
Most common reason: Particulate / foreign matter (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sulfamethoxazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
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.
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.
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.
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.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
cGMP deviations: Temperature abuse
Presence of Foreign Substance- Potential of metal contamination.
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Failed Dissolution Specifications
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
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