Meclizine hydrochloride 12.5 mg tablets recalled after failing tablet specifications
Amerisource Health Services is recalling one lot of Meclizine Hydrochloride Tablets USP 12.5 mg because the product failed tablet specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall for a failed tablet specification on a prescription medicine, with no injuries stated.
Plain-English summary
Amerisource Health Services LLC is recalling Meclizine Hydrochloride Tablets USP 12.5 mg, in 50-tablet packs (NDC 60687-775-65) and individual doses (NDC 60687-775-11), prescription only, distributed by American Health Packaging of Columbus, Ohio. About 697 cartons were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated because the product failed tablet specifications. The source record does not name which specification the product failed.
Affected product is lot 1024852 with an expiry date of 9/30/2026.
Patients and pharmacies can identify affected product by the NDC and lot number above, and may contact Amerisource Health Services LLC for further information.
The recalled product
- Product
- MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
- Brand
- MECLIZINE HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Prescription tablet
- Affected units
- 697
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #1024852
- Exp 9/30/2026
Distribution
Distributed nationwide across the United States.
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