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

Torrent Pharma recalls 200mg Carbamazepine tablets: Failed dissolution specs

Torrent Pharma recalls 200mg Carbamazepine tablets (NDC 13668-268-01) due to failed dissolution specifications. This may affect medication effectiveness. Contact for return instructions.

🇺🇸 FDA recall #D-0365-2022DrugTorrent Pharma ›
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Recalling firmTorrent Pharma Inc.150 Allen Rd Ste 102 · Basking Ridge, NJ 07920-3856
✎ GovInfoNow plain-language explainer

Torrent Pharma is recalling 200mg Carbamazepine tablets (NDC 13668-268-01) because they failed dissolution specifications. This could mean the medication doesn't work as intended, so affected users should contact the manufacturer for instructions. Read more at govinfonow.com/recall/35499-torrent-pharma-recalls-200mg-carbamazepine-tablets-failed-dissolution-specs.

Source Summary by GovInfoNow · govinfonow.com/recall/35499-torrent-pharma-recalls-200mg-carbamazepine-tablets-failed-dissolution-specs · Updated August 18, 2026 · FDA enforcement record: FDA #D-0365-2022

Cite this page

“Torrent Pharma recalls 200mg Carbamazepine tablets: Failed dissolution specs.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35499-torrent-pharma-recalls-200mg-carbamazepine-tablets-failed-dissolution-specs. Based on FDA recall #D-0365-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0365-2022%22&limit=1).

Torrent Pharma Inc. voluntarily recalled Carbamazepine Tablets, USP 200 mg due to failed dissolution specifications, according to the FDA. The Food and Drug Administration announced the Class II recall on December 2, 2021.

How to tell if you have it

  • Brand: Torrent Pharma
  • Product: Carbamazepine Tablets, USP 200 mg
  • Packaging: 100 Tablets Rx only
  • NDC: 13668-268-01
  • Lot code: 4J11G002
  • Expiration date: 08/2024
  • Quantity: 15,336 Bottles

The hazard

The recall addresses failed dissolution specifications for the drug. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Torrent Pharma Inc. has 14 other recalls on record since July 22, 2013. Other recent recalls of similar products include Torrent Fluoxetine Tablets Recall (May 27, 2025), Torrent Pantoprazole Tablets Recall (April 11, 2022), and Torrent Telmisartan/Hydrochlorothiazide Tablets Recall (December 1, 2021). Other recent recalls of similar products include Ajanta Pharma Recalls Ranolazine 1000mg Due to Dissolution Failure (September 17, 2026), Inventia Chlorthalidone Recall (September 3, 2026), and Inventia Healthcare Chlorthalidone Tablets Recall (June 5, 2026).

How to tell if you have this one

Check for the product name 'Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only' with NDC 13668-268-01. The batch number 4J11G002 was manufactured in Bharuch, India, and expires August 2024.

  • Brand
    Torrent Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Torrent Pharma Inc. for specific return or disposal instructions for the recalled tablets.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Dec 2, 202112. FDA classified it Class II: Jan 11, 202223. Published in FDA’s Enforcement Report: Jan 19, 202234. FDA terminated the recall: Oct 23, 2023420212023
  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-0365-2022 (December 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0365-2022 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