CLASS II Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report
Metoprolol Tartrate Tablets USP 100 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Metoprolol Tartrate Tablets USP 100 mg, distributed nationwide in the US. The recall was initiated on 9 Sep 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0812-2021
- FDA event ID
- 88639
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Metoprolol Tartrate
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Sep 2021
- FDA classified
- 20 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 9 Sep 2021 | Recall initiated by company | |
| 20 Sep 2021 | Classified by FDA | +11 days |
| 29 Sep 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Metoprolol Tartrate Tablets USP 100 mg recalled?
Yes. Aurobindo Pharma USA recalled Metoprolol Tartrate Tablets USP 100 mg on 9 Sep 2021. The recall is Class II and its status is Terminated. Recall number D-0812-2021.
Why was it recalled?
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Which lots are affected?
Lot: MJ1019025-A, Exp. date 04/2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Metoprolol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP, 50 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |