FDA DrugsClass II
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687...
Published: April 1, 2026Recall ID: D-0418-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed tablet specifications.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Columbus |
| State | OH |
| Openfda › Unii | HDP7W44CIO |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 995624 |
| Openfda › Rxcui › 2 | 995666 |
| Openfda › Spl id | 38437b2a-bc23-c6d7-e063-6294a90ac5db |
| Openfda › Brand name | MECLIZINE HYDROCHLORIDE |
| Openfda › Spl set id | af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5 |
| Openfda › Package ndc › 1 | 60687-775-11 |
| Openfda › Package ndc › 2 | 60687-775-01 |
| Openfda › Package ndc › 3 | 60687-775-65 |
| Openfda › Package ndc › 4 | 60687-730-11 |
| Openfda › Package ndc › 5 | 60687-730-01 |
| Openfda › Package ndc › 6 | 60687-730-65 |
| Openfda › Product ndc › 1 | 60687-730 |
| Openfda › Product ndc › 2 | 60687-775 |
| Openfda › Generic name | MECLIZINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | MECLIZINE HYDROCHLORIDE |
| Openfda › Manufacturer name | American Health Packaging |
| Openfda › Application number | ANDA201451 |
| Openfda › Original packager product ndc › 1 | 53746-441 |
| Openfda › Original packager product ndc › 2 | 53746-442 |
| Event id | 98526 |
| Address 1 | 2550 John Glenn Ave Ste A |
| Code info | Lot #1024852; Exp 9/30/2026 |
| Postal code | 43217-1188 |
| Report date | 20260401 |
| Product type | Drugs |
| Product quantity | 697 cartons |
| Reason for recall | Failed tablet specifications. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260316 |
| Initial firm notification | Letter |
| Center classification date | 20260331 |
Overview
- Recalling FirmAmerisource Health Services LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide