CLASS II Drug recall · Reported 24 Feb 2021 · FDA Enforcement Report
Meclizine HCl Tablets, USP, 25 mg recalled by Wilshire Pharmaceuticals
Wilshire Pharmaceuticals is recalling Meclizine HCl Tablets, USP, 25 mg, distributed in Florida, Texas. The recall was initiated on 4 Feb 2021 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-0259-2021
- FDA event ID
- 87268
- Recalling firm
- Wilshire Pharmaceuticals, Atlanta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2021
- FDA classified
- 16 Feb 2021
- Reported
- 24 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 4 Feb 2021 | Recall initiated by company | |
| 16 Feb 2021 | Classified by FDA | +12 days |
| 24 Feb 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01
Where it was distributed
FL, TX
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: 18030329, 18030330, 18030331, Exp 03/2021.
Where was it sold?
FL, TX
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.
Other products in this recall event
1 other product · FDA event 87268This product is part of a recall event; the main page for the event is Meclizine HCl Tablets, USP, 12.5 mg recalled by Wilshire Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Meclizine HCl Tablets, USP, 12.5 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |
More recalls from Wilshire Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Meclizine HCl Tablets, USP, 12.5 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |
Other Meclizine recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| 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, 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 |