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Lower risk Drug recall · FDA · Published March 10, 2022

Macleods Risedronate Tablets Recall: Failed Content Uniformity

Macleods Pharma recalls 5mg Risedronate tablets due to failed content uniformity. Affected lots may not contain correct active ingredient levels.

🇺🇸 FDA recall #D-0762-2022DrugMacleods ›
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Recalling firmMacleods Pharma Usa Inc666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ 08536-0009
✎ GovInfoNow plain-language explainer

Macleods Pharma is recalling 5mg Risedron: 30-count prescription tablets that failed content uniformity tests. This means some tablets may not contain the correct amount of active ingredient, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/35129-macleods-risedronate-tablets-recall-failed-content-uniformity.

Source Summary by GovInfoNow · govinfonow.com/recall/35129-macleods-risedronate-tablets-recall-failed-content-uniformity · Updated August 18, 2026 · FDA enforcement record: FDA #D-0762-2022

Cite this page

“Macleods Risedronate Tablets Recall: Failed Content Uniformity.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35129-macleods-risedronate-tablets-recall-failed-content-uniformity. Based on FDA recall #D-0762-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0762-2022%22&limit=1).

The FDA announced on March 10, 2022, that Macleods Pharma USA Inc. is recalling Risedronate Sodium Tablets, USP, 5 mg due to failed content uniformity specifications. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: Macleods
  • Product: Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle
  • NDC: 33342-107-07
  • Lot #: BRD2001A
  • Expiration: 5/2022
  • Quantity: 4872 bottles

The hazard

The tablets failed content uniformity specifications, which may result in the product not delivering the correct dose of medication to patients.

Context

GovInfoNow's records show Macleods Pharma USA, Inc. has 20 other recalls on record since December 24, 2015. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (August 3, 2026), Meclizine 12.5mg Tablets Recall (March 16, 2026), and Ascend Minocycline Tablets Recall (June 1, 2026).

How to tell if you have this one

Check for the 30-count bottle labeled 'Risedronate Sodium Tablets, USP, 5 mg, Rx Only'. The lot number BRD2001A was manufactured in Plainsboro, NJ and expires May 2022.

  • Brand
    Macleods
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number BRD2001A on the bottle label to confirm if your tablets are affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

1. Firm started the recall: Mar 10, 202212. FDA classified it Class III: Apr 7, 202223. Published in FDA’s Enforcement Report: Apr 13, 202234. FDA terminated the recall: Jun 29, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0762-2022 (March 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0762-2022 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