Use caution Drug recall · FDA · Published October 21, 2014

Taro Recalls Carbamazepine 200mg Tablets Due to Regulatory Issues

Taro Pharmaceuticals recalls specific lots of Carbamazepine Tablets USP 200 mg because they were marketed without an approved New Drug Application.

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

🇺🇸 FDA recall #D-0049-2015Drug Taro Pharmaceuticals ›

Use caution until it’s fixed

Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

Take action

Contact the company

Recalling firmTaro Pharmaceuticals U.S.A., Inc.3 Skyline Dr · Hawthorne, NY 10532-2174

✎ GovInfoNow plain-language explainer

Taro Pharmaceuticals U.S.A., Inc. is recalling one lot of Carbamazepine Tablets USP, 200 mg, distributed in Illinois, Ohio, and Louisiana. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Specifically, the lot was erroneously released from hold-pending status in the inventory system while an alternate manufacturing site for the active ingredient was still pending approval. Read more at govinfonow.com/recall/45646-taro-pharmaceuticals-u-s-a-inc-recalls-carbamazepine-tablets-usp.

Source Summary by GovInfoNow · govinfonow.com/recall/45646-taro-pharmaceuticals-u-s-a-inc-recalls-carbamazepine-tablets-usp · Updated October 12, 2026 · FDA enforcement record: FDA #D-0049-2015

Cite this page

“Taro Recalls Carbamazepine 200mg Tablets Due to Regulatory Issues.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45646-taro-pharmaceuticals-u-s-a-inc-recalls-carbamazepine-tablets-usp. Based on FDA recall #D-0049-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0049-2015%22&limit=1).

The FDA announced on Oct. 21, 2014, that Taro Pharmaceuticals U.S.A., Inc. recalled Carbamazepine Tablets USP, 200 mg, because they were marketed without an approved New Drug Application or Abbreviated New Drug Application. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Taro Pharmaceuticals
Product: Carbamazepine Tablets 200 mg
NDC: 51672-4005-3
Lot: 137393, exp. 10/2016
Distribution: IL, OH, LA

The hazard

The FDA said the product was marketed without an approved NDA/ANDA because one lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. Additionally, an alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

Context

GovInfoNow's records show Taro Pharmaceuticals U.S.A., Inc. has 20 other recalls on record since 2012-11-21. Other recent recalls of similar products include Taro Pharmaceuticals Hydrocortisone Otic Solution Recall (2024-08-07), Taro recalls Clotrimazole-Betamethas (2022-02-25), and Taro recalls Clobetasol Ointment with R. Pickettii bacteria risk (2021-12-15). Other recent recalls of similar products include Taro Recalls Children's Ibuprofen Due to Foreign Substance (2026-03-02), Xyvona (Levorphanol) 2mg Tablet Recall: FDA Denial of Marketing (2026-05-22), and Sun Pharmaceutical Carbamazepine Tablets Recall: Black Spots From Burnt Ingredients (2026-08-03).

How to tell if you have this one

Check your bottle for NDC 51672-4005-3 and Lot number 137393 with an expiration date of 10/2016. The product is Carbamazepine Tablets USP, 200 mg, sold in bottles containing 1,000 tablets. It was distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, NY.

Brand
Taro Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check your bottle details
Verify if your Carbamazepine Tablets have NDC 51672-4005-3 and Lot 137393 expiring in 10/2016.
Contact your pharmacy or doctor
If you have the recalled lot, speak with your healthcare provider or pharmacist about next steps for replacement or disposal.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “IL, OH, LA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Louisiana, Ohio.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Oct 21, 2014Firm started the recall
Oct 27, 2014FDA classified it Class III
Nov 5, 2014Published in FDA’s Enforcement Report
Apr 3, 2017FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/45646-taro-pharmaceuticals-u-s-a-inc-recalls-carbamazepine-tablets-usp">Taro Recalls Carbamazepine 200mg Tablets Due to Regulatory Issues (GovInfoNow)</a>

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-0049-2015 (October 21, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0049-2015 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.