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Lower risk Drug recall · FDA · Published September 2, 2021

Rising Pharmaceuticals Meclizine Tablets: Incorrect Instructions Hazard

Rising Pharmaceuticals recalls 25mg Meclizine HCl tablets with incorrect labeling instructions. Consumers should check product details and contact the company for guidance.

🇺🇸 FDA recall #D-0005-2022DrugRising Pharmaceuticals ›
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Recalling firmRISING PHARMACEUTICALS2 Tower Center Blvd · East Brunswick, NJ 08816-1100
✎ GovInfoNow plain-language explainer

Rising Pharmaceuticals is recalling 25mg Mecliz:ine HCl tablets in 100-count HDPE bottles due to incorrect labeling instructions. This could lead to improper use of the medication. Read more at govinfonow.com/recall/35869-rising-pharmaceuticals-meclizine-tablets-incorrect-instructions-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/35869-rising-pharmaceuticals-meclizine-tablets-incorrect-instructions-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #D-0005-2022

Cite this page

“Rising Pharmaceuticals Meclizine Tablets: Incorrect Instructions Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35869-rising-pharmaceuticals-meclizine-tablets-incorrect-instructions-hazard. Based on FDA recall #D-0005-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0005-2022%22&limit=1).

The FDA announced on September 2, 2021, that Rising Pharmaceuticals is recalling Meclizine HCl Tablets due to incorrect labeling instructions. The recall affects 1,344 bottles distributed by Rising Pharma Holdings, Inc.

How to tell if you have it

  • Brand: Rising Pharmaceuticals
  • Product: Meclizine HCl Tablets, 25 mg
  • Packaging: 100-count HDPE bottle
  • NDC: 16571-752-01
  • Lot #: CB21024
  • Expiration: 2/2023
  • Quantity: 1,344 bottles

The hazard

The hazard is incorrect labeling instructions. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Rising Pharmaceuticals has two other recalls on record since February 7, 2022. On February 15, 2023, the company recalled Warfarin Tablets due to impurities risk. On February 7, 2022, it recalled Methylphenidate Tablets due to size variation risks. Other recent recalls of similar products include Meclizine 12.5mg Tablets Recall (March 16, 2026), American Health Packaging Buprenorphine Tablets Recall (August 19, 2026), and American Regent Levocarnitine Injection Recall (April 16, 2026).

How to tell if you have this one

Check for Meclizine HCl Tablets, 25 mg, 100-count HDPE bottle packaging. The product was distributed by Rising Pharmaceuticals and manufactured by Aurex laboratories LLC.

  • Brand
    Rising Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product name, dosage, and packaging details to confirm if it matches the recalled items.

How this recall unfolded

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Sep 2, 202112. FDA classified it Class II: Oct 7, 202123. Published in FDA’s Enforcement Report: Oct 13, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0005-2022 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0005-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA