Levalbuterol tartrate HFA inhalation aerosol recalled for temperature abuse
Levalbuterol tartrate HFA inhalation aerosol is being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during storage and distribution. The FDA has classified this as a Class II recall.
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 no reported illnesses or injuries, and the hazard—temperature-compromised drug quality—is theoretical. This meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Levalbuterol tartrate HFA inhalation aerosol, 45 mcg/actuation (NDC 0591-2927-54) manufactured by Teva Pharma USA and distributed by McKesson Medical-Surgical Inc., is being recalled nationwide. The product was distributed in packages of 2 inhalers.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations related to temperature abuse during storage and distribution. Temperature exposure can affect medication quality and efficacy. Because McKesson Medical-Surgical cannot identify specific lot numbers by customer, recall notifications to customers include distribution dates to help determine if product received falls within the affected timeframe.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
- Brand
- LEVALBUTEROL TARTRATE HFA INHALATION
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Respiratory / Inhalation
- Affected units
- 2
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 · LEVALBUTEROL TARTRATE HFA INHALATION
- ModerateCardinal Health Recalls Levalbuterol Inhalers Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
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