Enalapril Maleate Tablets Recall Due to Impurity Test Failure
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (908 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 24, 2026.
Frequently Asked Questions
Common questions about this FDA recall.