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Drug FDA Class II Ongoing Failed specifications

Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.

Amerisource Health Services LLC Published Apr 1, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed tablet specifications.

Hazards

Failed Tablet Specifications · primary

Affected products (1)

Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.

MECLIZINE HYDROCHLORIDE · 697 cartons

NDC: 60687-730, 60687-775, 60687-775-11, 60687-775-01, 60687-775-65, 60687-730-11, 60687-730-01, 60687-730-65
Lot codes: 1024852
Code info: Lot #1024852; Exp 9/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 16, 2026
  2. Published
    Apr 1, 2026
Recall number
D-0418-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.