Prescription Antibiotic Tablets Recalled Due to Temperature Abuse
McKesson Medical-Surgical is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) nationwide due to cGMP deviations caused by temperature abuse during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription antibiotic due to cGMP deviations from temperature abuse. No adverse health consequences have been reported. The recall is classified as High because it involves a risk-of-harm scenario (potential drug instability) in the absence of reported injuries.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets, USP (800mg/160mg), a prescription antibiotic, distributed nationwide. The recall was initiated due to cGMP deviations that resulted from temperature abuse during manufacturing.
No adverse health consequences have been reported in association with this recall.
Patients currently taking this medication should contact their healthcare provider or pharmacist regarding whether their supply may be affected. Healthcare providers and pharmacies should consult the distribution dates provided in McKesson's recall notification letters to determine whether they received affected product.
The recalled product
- Product
- SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
- Brand
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Antibiotic
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
Same brand · SULFAMETHOXAZOLE AND TRIMETHOPRIM
- ModerateDouble strength antibiotic bottles recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- ModerateMajor Pharmaceuticals antibiotic cartons recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-17
- ModerateCardinal Health antibiotic tablets recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-17
- ModerateSulfamethoxazole and trimethoprim tablets recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-10
- SevereSulfamethoxazole and Trimethoprim Tablets Recalled for Microbial Contamination
FDA (Drugs) · 2025-06-18
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- SevereCrab Cakes Sold to Food Service Recalled for Botulism Risk
FDA (Food) · 2026-04-15
- CriticalUDENYCA syringes recalled after cartons were stored at room temperature
FDA (Drugs) · 2026-02-18