CLASS II ONGOING Drug recall · Reported 13 Oct 2021 · FDA Enforcement Report
Meclizine HCl Tablets, 25 mg recalled by Rising Pharmaceuticals
Rising Pharmaceuticals is recalling Meclizine HCl Tablets, 25 mg. The recall was initiated on 2 Sep 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-0005-2022
- FDA event ID
- 88593
- Recalling firm
- Rising Pharmaceuticals, East Brunswick, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Sep 2021
- FDA classified
- 7 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 2 Sep 2021 | Recall initiated by company | |
| 7 Oct 2021 | Classified by FDA | +35 days |
| 13 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect Instructions
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 HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Where it was distributed
to be entered
Questions about this recall
Why was it recalled?
Labeling: Incorrect Instructions
Which lots are affected?
Lot # CB21024, Exp 2/2023
Where was it sold?
to be entered
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.
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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, 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 |