Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Sep 9, 2021 (5 years ago)

Metoprolol Tartrate Tablets USP 100 mg

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

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

Affected NDC 65862-0064-99

Compare with the code on your package — it is the most precise check available.

Drug: Metoprolol Category: Blood Pressure Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Metoprolol Tartrate
NDC 65862-0064
100 mg/1 Tablet, Film Coated
Oral
Aurobindo Pharma Limited Rx
Recalling firm
Aurobindo Pharma USA Inc.
NDC code
65862-064-99
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0812-2021 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Metoprolol recalls

See all

Other recalls by Aurobindo Pharma USA Inc.

All 2021 recalls
Class II · Moderate risk

Acetaminophen Tablets

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Ongoing Failed specification Aurobindo Pharma USA Inc NDC 72288-405-10 D-0471-2025
Class II · Moderate risk

Nebivolol Tablets

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Ongoing Nitrosamine impurity Aurobindo Pharma USA Inc D-0149-2025
Class II · Moderate risk

Cinacalcet Tablets

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Ongoing Nitrosamine impurity Aurobindo Pharma USA Inc NDC 65862-833-30 D-0079-2025