OVERLOOKED

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Class IIOngoing

SUN PHARMACEUTICAL INDUSTRIES INC recalls Carbamazepine Tablets

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
SUN PHARMACEUTICAL INDUSTRIES INC
Reason
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99562…

Products

  1. Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

    Codes/lots: Lot # AD94033, Exp Date: 5/31/2028.Quantity: 1968 Bottles (1000Tablets/Bottle)Recall no. D-0770-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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