Drug FDA Class II Ongoing Foreign material

Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00

Rubicon Research Private Limited Published Jun 5, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Rubicon Research Private Limited or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Presence of Foreign Substance: metal in tablet

Hazards

Metal Particulate · primary

Affected products (1)

Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00

METOPROLOL TARTRATE · 11,664 Bottles

NDC: 52817-358, 52817-362, 52817-359, 52817-361, 52817-360, 52817-362-10, 52817-362-00, 52817-359-10, 52817-359-50, 52817-361-10, 52817-361-00, 52817-360-10, 52817-360-00, 52817-358-10, 52817-358-50

Lot codes: 231037H1

Code info: Lot 231037H1, exp 6/2027

Affected areas

Nationwide

Timeline

Initiated

May 6, 2024
Published

Jun 5, 2024

Recall number: D-0517-2024
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.