CLASS II Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalled

Shamrock Medical Solutions Group is recalling Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, Double Strength, Rx, packaged, distributed in Colorado, Massachusetts, Ohio, Texas, Wyoming. The recall was initiated on 27 Sep 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 00288N, Use By: 9/15/2012, NDC 53746-272-01

NDC53746-271, 53746-272

UPC0353746271013, 0353746272010

Quantity recalled284/800 mg tablets

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1450-2014
FDA event ID: 64611
Recalling firm: Shamrock Medical Solutions Group, Lewis Center, OH
Brand: Sulfamethoxazole And Trimethoprim
Manufacturer: Amneal Pharmaceuticals of New York LLC
Classification: Class II
Status: Terminated
Recall initiated: 27 Sep 2011
FDA classified: 23 Jul 2014
Reported: 30 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Packaging Defects
Drug class: Antibiotics

Timeline

27 Sep 2011	Recall initiated by company
23 Jul 2014	Classified by FDA	+1030 days
30 Jul 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01

Where it was distributed

Product was shipped to the following states: CO, MA, OH, TX & WY.

Colorado Massachusetts Ohio Texas Wyoming

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01

Where was it sold?

Product was shipped to the following states: CO, MA, OH, TX & WY.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 64611

This product is part of a recall event; the main page for the event is metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled.

Reported	Class	Recall	Company	Reason	Where
30 Jul 2014	CLASS I	metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS II	Docusate Calcium Softgel Capsules, 240 mg recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS I	Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS I	Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS II	Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states

Reported	Class	Recall	Company	Reason	Where
30 Jul 2014Drug	CLASS II	Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS I	Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS I	Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS II	Docusate Calcium Softgel Capsules, 240 mg recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS I	metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states

Other Sulfamethoxazole recalls

All 15

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Northwind Pharmaceuticals	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Packaging Defects	Nationwide
18 Jun 2025Drug	CLASS I	Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Sterility	Nationwide