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
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 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