Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

Is Trimethoprim recalled?

Yes — there is an active recall. 6 ongoing FDA recalls mention Trimethoprim (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 Trimethoprim. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Trimethoprim recalls on record

none so far in 2026; 18 on record, newest first
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim

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.

Ongoing Particulate / foreign matter The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 55154-7895-0 D-0625-2025
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim

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.

Ongoing Particulate / foreign matter The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-2725-61 D-0624-2025
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim 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.

Ongoing Particulate / foreign matter Northwind Pharmaceuticals LLC NDC 51655-307-87 D-0654-2025
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim 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.

Ongoing Particulate / foreign matter Amneal Pharmaceuticals, LLC NDC 65162-272-10 D-0615-2025
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim Tablets USP

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.

Terminated Particulate / foreign matter Sun Pharmaceutical Industries, Inc. NDC 53489-146-05 D-0802-2018
Class II · Moderate risk

Trimethoprim/sulfadiazine excipient stock solution injection…

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0145-2015
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim Tablets

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

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-272-01 D-1450-2014