Reported Jul 5, 2023 · Terminated

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical…

The Harvard Drug Group

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: The Harvard Drug Group · 341 Mason Rd · La Vergne, TN · 37086-3606

Is this the product you have?

    • Tramadol Hydrochloride Tablets
    • USP 50 mg
    • Unit Dose 100-Count Tablets Rx only
  • Manufactured bySun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India
  • Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
  • Distributed by
    • Major Pharmaceuticals Livonia
    • MI 48152 USA
    • NDC 0904-7179-61
Lot codes and dates
    • Lot #: M04343
    • Exp. 04/2024
Amount recalled
3876 cartons

Where it was sold

  • Nationwide

Why it was recalled

Packaging defect: blister packaging inadequately sealed.

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 Apr 30, 2024 · Data as of Sep 19, 8:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.