CLASS II ONGOING Drug recall · Reported 1 Apr 2026 · FDA Enforcement Report
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalled
Amerisource Health Services is recalling Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] (, distributed nationwide in the US. The recall was initiated on 16 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0418-2026
- FDA event ID
- 98526
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Manufacturer
- American Health Packaging
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Mar 2026
- FDA classified
- 31 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 16 Mar 2026 | Recall initiated by company | |
| 31 Mar 2026 | Classified by FDA | +15 days |
| 1 Apr 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed tablet specifications.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed tablet specifications.
Which lots are affected?
Lot #1024852; Exp 9/30/2026
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 2 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Meclizine recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP, 25 mg cartons recalledMeclizine Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Meclizine HCl Tablets, 25 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Packaging Defects | NJ |
| Drug | CLASS II | Meclizine HCl Tablets, USP, 25 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |
| Drug | CLASS II | Meclizine HCl Tablets, USP, 12.5 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |
| Drug | CLASS III | Wal-dram 2 (meclizine Hydrochloride) recalled by Sato PharmaceuticalWal-dram 2 Quick-dissolving | Sato Pharmaceutical | Potency & Assay | Nationwide |