Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC...

FDA Drug Recall #D-0517-2024 — Class II — May 6, 2024

Recall Summary

Recall Number D-0517-2024
Classification Class II — Moderate risk
Date Initiated May 6, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Rubicon Research Private Limited
Location Ambarnath
Product Type Drugs
Quantity 11,664 Bottles

Product Description

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

Reason for Recall

Presence of Foreign Substance: metal in tablet

Distribution Pattern

Nationwide

Lot / Code Information

Lot 231037H1, exp 6/2027

Other Recalls from Rubicon Research Private Limited

Recall # Classification Product Date
D-0659-2024 Class III AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count b... Aug 24, 2024
D-0487-2024 Class II traMADol Hydrochloride Tablets, USP 50 mg, 1000... Apr 26, 2024
D-0362-2022 Class II Metoprolol Tartrate Tablets, USP 25 mg, 1000 - ... Dec 31, 2021

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.