FDA Recall Metformin Hydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on May 4th, 2021 and classified as a Class II recall due to presence of foreign substance: identified as activated carbon. This recall is currently terminated, and the associated recall number is recall number is D-0372-2021. It pertains to Metformin Hydrochloride identified by 62756-142 as of 06-27-2023 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0372-2021 | 05-04-2021 | 05-19-2021 | 50868 bottles | 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. | Presence of foreign substance: identified as activated carbon. | Terminated |
| D-0325-2021 | 03-25-2021 | 04-14-2021 | 2520 bottles | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, 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. | Failed Moisture Limits: Out of specification for water content | Terminated |
| D-0924-2018 | 07-03-2018 | 07-25-2018 | 2508 bottles | Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, 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 | Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet. | Terminated |
| D-1089-2014 | 01-28-2014 | 03-05-2014 | 2528 bottles | 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 | Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
