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Unrated Drug recall · FDA · Published May 18, 2016

Teva Recalls Divalproex Sodium 250mg Tablets Due to Spec Failures

Teva North America recalls specific lots of Divalproex Sodium Delayed-release Tablets USP, 250 mg, due to failed tablet specifications.

🇺🇸 FDA recall #D-1449-2016DrugTeva ›
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Recalling firmTeva North America425 Privet Rd · Horsham, PA 19044-1220
✎ GovInfoNow plain-language explainer

What happened, in plain English

Teva North America is recalling Divalproex Sodium Delayed-release Tablets USP, 250 mg, in 100 count bottles. The recall was initiated because the product failed to meet established tablet specifications. The affected units were distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42608-teva-recalls-divalproex-sodium-250mg-tablets-due-to-spec-failures.

Source Summary by GovInfoNow · govinfonow.com/recall/42608-teva-recalls-divalproex-sodium-250mg-tablets-due-to-spec-failures · Updated October 9, 2026 · FDA enforcement record: FDA #D-1449-2016

Cite this page

“Teva Recalls Divalproex Sodium 250mg Tablets Due to Spec Failures.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42608-teva-recalls-divalproex-sodium-250mg-tablets-due-to-spec-failures. Based on FDA recall #D-1449-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1449-2016%22&limit=1).

Why it’s dangerous

The record states the tablets failed specifications but does not describe the specific nature of the failure or any resulting health risks to consumers.

Who’s affected

Patients who have been prescribed Divalproex Sodium Delayed-release Tablets USP, 250 mg, manufactured by Teva Pharmaceuticals Ind. Ltd. in Israel for Teva Pharmaceuticals USA, Inc.

How to tell if you have this one

Check your medication bottle for the brand name Teva, NDC 0093-7440-01, Lot # 02D163, and an expiration date of 9/2017. The product is a 250 mg delayed-release tablet in a 100 count bottle.

  • Brand
    Teva
  • Category
    Drug

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 8 months after the firm started it.

1. Firm started the recall: May 18, 201612. FDA classified it Class III: Jul 27, 201623. Published in FDA’s Enforcement Report: Aug 3, 201634. FDA terminated the recall: Jan 17, 2017420162017
  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-1449-2016 (May 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1449-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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