Meclizine Hydrochloride Tablets Recalled for Manufacturing Temperature Control Deviations
Mckesson Medical-Surgical is recalling Meclizine Hydrochloride 25mg tablets nationwide due to manufacturing deviations involving improper temperature control. The FDA 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 is an FDA Class II recall for manufacturing deviations involving temperature control failures. While no illnesses or injuries are mentioned in the recall notice, the defect presents a potential risk to product safety and efficacy, as improper temperature control could affect drug stability.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Meclizine Hydrochloride 25mg tablets (NDC 50268-523-15) manufactured by Avkare Inc. that were distributed nationwide in the United States. The product is a prescription oral medication.
The recall was issued due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process. Improper temperature control may affect the quality and stability of the product.
Patients and healthcare providers who have received this medication should contact Mckesson Medical-Surgical for guidance. The company has notified affected customers directly regarding lot numbers and distribution dates specific to their shipments.
The recalled product
- Product
- MECLIZINE HYDROCHLORIDE (MECLIZINE)
- Brand
- MECLIZINE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- manufacturing-deviation
- temperature-abuse
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · MECLIZINE HYDROCHLORIDE
- SevereMeclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
FDA (Drugs) · 2022-04-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateClomiphene Citrate USP Active Pharmaceutical Ingredient Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-15
- SevereBortezomib for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- ModerateDrogueria San Juan Isopropyl Alcohol 70% Recalled for Subpotency
FDA (Drugs) · 2026-07-15