CLASS II Drug recall · Reported 19 May 2021 · FDA Enforcement Report
Metformin HCl Extended-Release Tablets, USP, 500 mg recalled
SUN Pharmaceutical Industries is recalling Metformin HCl Extended-Release Tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 4 May 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-0372-2021
- FDA event ID
- 87869
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2021
- FDA classified
- 7 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 4 May 2021 | Recall initiated by company | |
| 7 May 2021 | Classified by FDA | +3 days |
| 19 May 2021 | 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 substance: identified as activated carbon.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign substance: identified as activated carbon.
Which lots are affected?
Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023.
Where was it sold?
USA Nationwide
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 26 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 SUN Pharmaceutical Industries
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
Other Metformin recalls
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalled | Glenmark Pharmaceuticals Inc., USA | 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, USP, 500 mg recalledMetformin Er 500 Mg | Granules Pharmaceuticals | Other | OH |
| 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 |