Ramipril Capsules USP 10 mg Recall Issued
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Hikma Pharmaceuticals USA INC. is recalling specific lots of Ramipril Capsules USP, 10 mg due to failed impurities specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 7, 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, drug.
What Happened
Hikma Pharmaceuticals USA INC. initiated a voluntary recall due to Failed Impurities/Degradation Specifications after an OOS result was obtained for a process impurity, dicyclohexylurea (DCU).
Which Products Are Affected
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles. Affected lots are AC5470A (25,970 bottles) and AC5470B (2,384 bottles), both with expiration date July 2027. The products were manufactured for Exelan Pharmaceuticals, Inc. and distributed nationwide within the United States.
What You Should Do
Consumers should consult their healthcare provider regarding the recalled product.
Why This Matters
This Class II recall involves 28,354 bottles of prescription medication distributed across the United States.
Source
FDA recall number D-0831-2026
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 (870 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.