CLASS III Drug recall · Reported 28 Feb 2018 · FDA Enforcement Report
Metformin Hydrochloride Tablets, USP 1000 mg recalled
Aurobindo Pharma is recalling Metformin Hydrochloride Tablets, USP 1000 mg, distributed nationwide in the US. The recall was initiated on 2 Feb 2018 and the FDA has classified it as Class III.
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-0427-2018
- FDA event ID
- 79119
- Recalling firm
- Aurobindo Pharma, East Windsor, NJ
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Feb 2018
- FDA classified
- 16 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 2 Feb 2018 | Recall initiated by company | |
| 16 Feb 2018 | Classified by FDA | +14 days |
| 28 Feb 2018 | Published in enforcement report | +12 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 Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Product as listed by the FDA
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
Where it was distributed
Nationwide within the US
Questions about this recall
Is Metformin Hydrochloride Tablets, USP 1000 mg recalled?
Yes. Aurobindo Pharma recalled Metformin Hydrochloride Tablets, USP 1000 mg on 2 Feb 2018. The recall is Class III and its status is Terminated. Recall number D-0427-2018.
Why was it recalled?
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Which lots are affected?
Lot#: MTSC17145-A, Exp. July 2021
Where was it sold?
Nationwide within the US
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Aurobindo Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Ampicillin and Sulbactam for Injection vial recalled by Aurobindo PharmaAmpicillin And Sulbactam | Aurobindo Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Northstar Zolpidem Tartrate Tablets USP 10 mg recalled | Aurobindo Pharma | Other | Nationwide |
Other Metformin recalls
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | Nationwide |