Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Summary
The FDA issued a Class II for Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tabl by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) wa.
Details
Source
Drug Recall
External ID
D-0624-2025
Action Date
2025-09-17
Status
Ongoing
Category
drug
Product Description
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
Lot/Code Info: Lot # N02309, Exp 03/31/2027
Quantity Affected: N/A
Reason for Recall
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.
Distribution
USA Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-02
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 68 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories have FDA actions?
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0624-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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