CLASS II Drug recall · Reported 5 Mar 2014 · FDA Enforcement Report
Metformin HCl Extended-Release Tablets, USP, 500 mg recalled
Caraco Pharmaceutical Laboratories is recalling Metformin HCl Extended-Release Tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 28 Jan 2014 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-1089-2014
- FDA event ID
- 67433
- Recalling firm
- Caraco Pharmaceutical Laboratories, Detroit, MI
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2014
- FDA classified
- 26 Feb 2014
- Reported
- 5 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 28 Jan 2014 | Recall initiated by company | |
| 26 Feb 2014 | Classified by FDA | +29 days |
| 5 Mar 2014 | Published in enforcement report | +7 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; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Product as listed by the FDA
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Which lots are affected?
Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016
Where was it sold?
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 Caraco Pharmaceutical Laboratories
All 12Other Metformin recalls
All 61| 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 |