Class II · ModerateRecall completed
Metformin Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023.
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of foreign substance: identified as activated carbon.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made bySun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India foreign manufacturer
| Brand name | METFORMIN HYDROCHLORIDE |
| Generic name | METFORMIN HYDROCHLORIDE |
| Active ingredient(s) | METFORMIN HYDROCHLORIDE |
| Distributed by / for | Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 |
| NDC | 62756-142-02 |
Show the full FDA record
| Full product label | Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02. |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Distribution | USA Nationwide |
| Quantity | 50868 bottles |
| Recall initiated | 2021-05-04 |
| Report date | 2021-05-19 |
| Recall completed | 2023-06-27 |
| Recall number | D-0372-2021 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.