Recalls / Class II
Class IID-0418-2026
Product
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.
- Brand name
- Meclizine Hydrochloride
- Generic name
- Meclizine Hydrochloride
- Active ingredient
- Meclizine Hydrochloride
- Route
- Oral
- NDCs
- 60687-730, 60687-775
- FDA application
- ANDA201451
- Affected lot / code info
- Lot #1024852; Exp 9/30/2026
Why it was recalled
Failed tablet specifications.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 697 cartons
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2026-03-16
- FDA classified
- 2026-03-31
- Posted by FDA
- 2026-04-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0418-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.