FDA Recalls Olanzapine Tablets Due to Temperature Abuse in Manufacturing
McKesson Medical-Surgical is recalling Olanzapine Orally Disintegrating Tablets 10 mg nationwide due to temperature abuse during manufacturing that may have affected product stability. Patients should consult their healthcare provider about their medication.
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 FDA Class II recall involves cGMP deviations affecting a prescription antipsychotic medication. Although no illnesses or injuries have been reported, temperature abuse during manufacturing represents a risk-of-harm to medication stability and efficacy that could affect patients dependent on consistent therapeutic treatment.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Olanzapine Orally Disintegrating Tablets, USP 10 mg (NDC 49884-321-55) nationwide. The recall was initiated due to current good manufacturing practice (cGMP) deviations involving temperature abuse during the manufacturing process.
The affected product is manufactured by PAR PHARMA and distributed by McKesson in 30-count unit dose boxes containing three blister cards with 10 tablets each. The product was distributed nationwide to pharmacy customers and healthcare facilities.
Temperature abuse during manufacturing can affect medication stability and quality. Patients currently taking this medication should not stop treatment without consulting their healthcare provider or pharmacist, as abrupt discontinuation of antipsychotic medication can pose health risks. Those who received this product should contact McKesson Medical-Surgical to determine whether their shipments are affected, since the company is unable to identify specific lot numbers distributed to individual customers.
Patients experiencing concerns or questions about their medication should contact their healthcare provider or pharmacist immediately.
The recalled product
- Product
- Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
- cgmp-deviation
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