Metronidazole Tablets Recalled for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Metronidazole 250 mg tablets manufactured by Major Pharma due to temperature deviations during manufacturing that could affect drug potency. Patients should consult their pharmacist or doctor.
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: FDA Class II classification indicates a manufacturing defect with potential to cause health consequences. Temperature abuse of metronidazole tablets could reduce drug efficacy and cause treatment failure. No illnesses or injuries have been reported, limiting severity to at most a 3.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Metronidazole tablets, USP 250 mg, 100-count unit dose boxes (NDC 0904-1453-61) manufactured by Major Pharma. The recall is due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. Temperature deviations can affect drug stability and potency.
The recalled product was distributed nationwide across the United States. The FDA has classified this as a Class II recall. Specific lot numbers cannot be identified; customers have been notified by distribution date to determine if they received affected product.
Healthcare facilities, pharmacies, and distributors who received this product should stop dispensing it immediately and consult the recall notice for further instructions. Patients who have taken this medication should not stop treatment without consulting their healthcare provider, but should discuss the recall with their doctor or pharmacist.
The recalled product
- Product
- Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Antibiotic
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27