Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Ph...

FDA Drug Recall #D-0812-2021 — Class II — September 9, 2021

Recall Summary

Recall Number D-0812-2021
Classification Class II — Moderate risk
Date Initiated September 9, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Aurobindo Pharma USA Inc.
Location East Windsor, NJ
Product Type Drugs
Quantity 2,820 bottles

Product Description

Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99

Reason for Recall

Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.

Distribution Pattern

Nationwide within the United States

Lot / Code Information

Lot: MJ1019025-A, Exp. date 04/2022

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D-1171-2023 Class II Rasagiline Tablets 0.5mg, 30-count bottle, Rx o... Aug 2, 2023
D-1087-2023 Class II Rufinamide Tablets, USP 200 mg, packaged in 120... Jul 21, 2023
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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.