ENALAPRIL MALEATE Recalled: Class II Recall Explained

Overview

A drug recall is a voluntary or FDA-requested action taken by a manufacturer to remove a medication from the market, or to correct it, because it does not meet safety, quality, or labeling standards. Recalls are one of the primary tools the FDA and drug manufacturers use to protect patients once a problem is discovered after a product has already reached pharmacies and consumers.

This specific drug recall involving ENALAPRIL MALEATE is classified as Class II, and was reported on May 13, 2026 by JB Chemicals and Pharmaceuticals Ltd.

The sections below explain, in plain language, what is known about this drug recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.

What Happened

JB Chemicals and Pharmaceuticals Ltd initiated action on ENALAPRIL MALEATE on May 13, 2026 after identifying a product quality or potency issue. The action affects specific lots or units of this medication rather than every unit ever produced, so not every package on the market is necessarily involved.

The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.

Affected Products

The product identified in this notice is ENALAPRIL MALEATE, manufactured or distributed by JB Chemicals and Pharmaceuticals Ltd.

FDA records describe the affected product as: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.

Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Lot #: GEH25023, Expires: 6/30/2027; a reported quantity of 675 bottles; distribution reported as Nationwide in the USA; origin or reporting location of Mumbai, India. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.

Reason

Based on FDA records, this notice was driven by a product quality or potency issue. In general terms, this kind of issue is flagged because it has the potential to affect how safely or effectively the product performs once it reaches a patient.

According to the FDA's Drug Enforcement Report database, the stated reason was: "Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test"

The underlying cause of an issue like this can range from a manufacturing deviation at a single facility to a broader design or formulation problem. The official FDA record linked at the end of this article is the authoritative source for the full technical explanation.

Health Risks

This notice is classified Class II. A Class II classification means the product may cause temporary or medically reversible health consequences, and the probability of serious adverse health consequences is considered remote. Most people affected by a Class II issue do not experience lasting harm, but temporary symptoms are possible.

The specific health risk depends heavily on the nature of the underlying issue with ENALAPRIL MALEATE — for example, a contamination concern carries a different risk profile than a labeling error, and a device malfunction carries a different risk profile than a potency issue. Read the "Reason" section above together with this section rather than in isolation.

Recommended Actions

Do not stop taking a recalled prescription medication abruptly without first talking to your prescriber or pharmacist — for many conditions, the health risk of suddenly stopping treatment can be greater than the risk described in this recall. Contact your pharmacy to ask whether the specific lot you have is on the affected list.

Check the lot numbers, NDC codes, or serial numbers on your product against the identifiers listed in the official FDA record (linked at the end of this article), since recalls often apply to specific batches rather than an entire product line.

Follow the specific instructions in the official notice regarding whether to return the product to the pharmacy or manufacturer, dispose of it, or simply stop use and await further guidance. Report any adverse effects you experienced while using this product to the FDA's MedWatch program (fda.gov/medwatch or 1-800-FDA-1088).

Who Should Be Concerned

This notice is most directly relevant to patients and caregivers who currently have ENALAPRIL MALEATE in their possession, pharmacies and distributors who stock it, and clinicians who prescribe or use it. If none of those describe you, this notice has limited practical relevance beyond general awareness.

If you are unsure whether this notice applies to you, the safest approach is to check your own product packaging or prescription against the identifying details in the official FDA record, or simply ask your pharmacist directly.

Important Dates

This notice was reported to the FDA on May 13, 2026. That date reflects when the record was published or reported, which may be after the underlying issue was first identified internally by the manufacturer.

For reference, FDA records associate this notice with recall number D-0520-2026 and event ID 98794. You can use this identifier to search for the most current status directly on FDA.gov.

Recall status, label language, and safety communications can all be updated after initial publication as the FDA and the responsible firm gather more information. Treat any specific date in this article as accurate as of when this article was generated, and confirm current status against the official source before making decisions.