Reported Dec 28, 2022 · Terminated

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC…

Sun Pharmaceutical Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only
  • Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
  • Manufactured bySun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India
Lot codes and dates
    • a) Lot HAC1474A
    • Expires 03/2023 b) Lot HAC1503A
    • Expires 03/2023 c) Lot HAC1474B
    • Expires 03/2023
Amount recalled
Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of foreign substance

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 13, 2023 · Data as of Sep 19, 5:55 PM UTC

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