Enalapril Maleate Tablets Recall Due to Impurity Test Failure
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Rising Pharma Holdings, Inc. is recalling 675 bottles of Enalapril Maleate Tablets, USP 20 mg after failing organic impurities specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 24, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
JB Chemicals and Pharmaceuticals Ltd initiated a voluntary recall of Enalapril Maleate Tablets after an out-of-specification result occurred in the Organic Impurities Test.
Which Products Are Affected
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle (NDC 64980-688-10), Rx only. Lot #: GEH25023, Expires: 6/30/2027. 675 bottles distributed nationwide in the USA. Manufactured by Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai, India; Distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ.
What You Should Do
Consumers should contact their healthcare provider or pharmacist regarding the recalled product.
Why This Matters
The Class II recall affects prescription medication distributed across the United States.
Source
FDA recall D-0520-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
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