CLASS II Drug recall · Reported 27 Jan 2016 · FDA Enforcement Report

Sulfamethoxazole and Trimethoprim Tablets recalled

Mutual Pharmaceutical is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, distributed in Mississippi. The recall was initiated on 9 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 6727001 Exp 01/18

Quantity recalled9526

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-0572-2016
FDA event ID: 72382
Recalling firm: Mutual Pharmaceutical, Philadelphia, PA
Classification: Class II
Status: Terminated
Recall initiated: 9 Oct 2015
FDA classified: 19 Jan 2016
Reported: 27 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Antibiotics

Timeline

9 Oct 2015	Recall initiated by company
19 Jan 2016	Classified by FDA	+102 days
27 Jan 2016	Published in enforcement report	+8 days

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

Reason for recall

Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

Product as listed by the FDA

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01

Where it was distributed

Mississippi

Questions about this recall

Why was it recalled?

Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

Which lots are affected?

Lot # 6727001 Exp 01/18

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Sulfamethoxazole recalls

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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
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