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Use caution Drug recall · FDA · Published July 11, 2014

Sandoz Recalls Orphenadrine Citrate Extended Release Tablets Due to Dissolution Failure

Sandoz Inc. recalls specific lots of Orphenadrine Citrate Extended Release Tablets, 100 mg, because they failed dissolution specifications during stability testing.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1445-2014DrugSandoz ›
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Recalling firmSandoz Inc506 Carnegie Ctr · Princeton, NJ 08540-6243
✎ GovInfoNow plain-language explainer

Sandoz Inc. is recalling specific lots of Orphenadrine Citrate Extended Release Tablets, 100 mg, because the product was found to be out of specification during stability testing. The issue involves failed dissolution specifications, meaning the drug may not release properly in the body. The recall affects 781,000 tablets distributed nationwide. Read more at govinfonow.com/recall/45954-sandoz-inc-recalls-orphenadrine-citrate-extended-release-tablets-100-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/45954-sandoz-inc-recalls-orphenadrine-citrate-extended-release-tablets-100-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1445-2014

Cite this page

“Sandoz Recalls Orphenadrine Citrate Extended Release Tablets Due to Dissolution Failure.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45954-sandoz-inc-recalls-orphenadrine-citrate-extended-release-tablets-100-mg. Based on FDA recall #D-1445-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1445-2014%22&limit=1).

The FDA announced on July 11, 2014, that Sandoz Inc voluntarily recalled Orphenadrine Citrate Extended Release Tablets due to failed dissolution specifications. The agency stated the product was found out of specification during stability testing.

How to tell if you have it

  • Brand: Sandoz
  • Product: Orphenadrine Citrate Extended Release Tablets, 100 mg
  • NDC 0185-0022-01 (100-count bottle)
  • NDC 0185-0022-10 (1000-count bottle)
  • Lot # DM1316; Exp. 05/16
  • Lot # DM1318; Exp. 05/16

The hazard

The recall was issued because the Orphenadrine Citrate Extended Release Tablets failed to meet dissolution specifications during stability testing, according to the FDA.

Context

GovInfoNow's records show Sandoz Inc has had 29 other recalls on record since October 9, 2013. Other recent recalls of similar products include Ajanta Pharma Recalls Ranolazine 1000mg Due to Dissolution Failure (September 17, 2026), Lannett Niacin Extended-release Tablets Recall: Failed Dissolution Testing (May 27, 2026), and AvKARE Rosuvastatin Tablets 10mg Recall: Dissolution Issue (December 31, 2025).

How to tell if you have this one

Check your bottle for NDC numbers 0185-0022-01 (100-count) or 0185-0022-10 (1000-count). Verify the lot number is either DM1316 or DM1318 and the expiration date is 05/16.

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

What to do — step by step

  1. Check your medication details

    Verify if your bottle matches NDC 0185-0022-01 or 0185-0022-10 with lot numbers DM1316 or DM1318 and expiration date 05/16.

  2. Contact your healthcare provider

    Speak with your doctor or pharmacist about the recall to determine if you need a replacement or alternative treatment, as no specific remedy is provided in the record.

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: “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 3 years after the firm started it.

1. Firm started the recall: Jul 11, 201412. FDA classified it Class III: Jul 23, 201423. Published in FDA’s Enforcement Report: Jul 30, 201434. FDA terminated the recall: Jul 10, 2017420142017
  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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Other Sandoz recalls

Sandoz Inc recalls Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal
June 1, 2026

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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-1445-2014 (July 11, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1445-2014 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 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