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Use caution Drug recall · FDA · Published February 5, 2016

Teva Recalls Paricalcitol Capsules Due to Impurity Issues

Teva Pharmaceuticals recalls specific lots of Paricalcitol Capsules, 1 mcg, due to failed impurity specifications. Check your bottle's lot number and expiration date.

🇺🇸 FDA recall #D-0774-2016DrugTeva Pharmaceuticals ›
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Recalling firmTeva Pharmaceuticals USA1090 Horsham Rd · North Wales, PA 19454-1505
✎ GovInfoNow plain-language explainer

What happened, in plain English

Teva Pharmaceuticals USA has recalled Paricalcitol Capsules, 1 mcg, because they failed impurity specifications during stability testing. The affected product was manufactured by Pharmaceutics International, Inc., for Teva. This recall covers 30,891 bottles distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/43170-teva-recalls-paricalcitol-capsules-due-to-impurity-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/43170-teva-recalls-paricalcitol-capsules-due-to-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-0774-2016

Cite this page

“Teva Recalls Paricalcitol Capsules Due to Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43170-teva-recalls-paricalcitol-capsules-due-to-impurity-issues. Based on FDA recall #D-0774-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0774-2016%22&limit=1).

Why it’s dangerous

The capsules failed out-of-specification test results for impurities during stability testing. This means the chemical composition of the drug may have degraded or contained unexpected substances beyond allowed limits.

Who’s affected

Patients currently taking Paricalcitol Capsules, 1 mcg, who purchased the specific recalled lots are affected. While the record does not specify immediate injury risks, individuals with these bottles should verify their product details.

How to tell if you have this one

Check your bottle for NDC 0093-7656-56 and Lot # 13013.009A with an expiration date of 02/2016. The product is labeled as Rx Only, manufactured by Pharmaceutics International, Inc., Hunt Valley, MD, for Teva Pharmaceuticals USA.

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

What to do — step by step

  1. Check Your Bottle Details

    Verify if your Paricalcitol Capsules match NDC 0093-7656-56 and Lot # 13013.009A with an expiration date of 02/2016.

  2. Contact Your Pharmacist

    If you have the recalled product, consult your pharmacist or healthcare provider for guidance on replacement or discontinuation.

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: yesFLPuerto Rico: yesPR

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Feb 5, 201612. FDA classified it Class II: Mar 11, 201623. Published in FDA’s Enforcement Report: Mar 23, 201634. FDA terminated the recall: Jan 13, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class II
  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-0774-2016 (February 5, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0774-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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