Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance
Sun Pharmaceutical Industries is recalling 50,868 bottles of Metformin Hydrochloride Extended-Release Tablets because activated carbon was found in the product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign substance (activated carbon) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 50,868 bottles of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg. The product is packaged in 500-count bottles and is available by prescription only. The recall covers specific lots with expiration dates of 6/2032 and 7/2023, distributed nationwide in the United States.
The recall was initiated due to the presence of a foreign substance identified as activated carbon in the tablets. The source text does not report any illnesses or injuries associated with this contamination.
Consumers who have these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance. The affected product is identified by NDC 62756-142-02 and specific lot numbers listed in the recall documentation.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 50,868
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lots #: JKX2749A
- JKX2803A
- JKX2804A
- JKX2805A
- JKX806A
- JKX2945A
- JKX2946A
- JXK2947A
- JKX2948A
- JKX2952A
- JKX2953A
- JKX2954A & JKX3224A
- Exp 6/2032
- JKX3211A
- JKX3212A
- Exp 7/2023.
UPCs (2)
- 0362756142015
- 0362756143012
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · METFORMIN HYDROCHLORIDE
- ModerateMetformin Hydrochloride Extended-Release Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2025-04-16
- HighMetformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-04-02
- SevereMetformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2022-02-02
- HighMetformin Hydrochloride Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2021-06-30
- LowSun Pharmaceutical Recalls Metformin Hydrochloride Extended-Release Tablets
FDA (Drugs) · 2021-04-14
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01