Acella Naproxen Oral Suspension Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Acella Pharmaceuticals is recalling 6,336 bottles of Naproxen Oral Suspension due to chemical contamination with lead and lithium above specification.
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
Acella Pharmaceuticals, LLC initiated a voluntary recall due to chemical contamination; presence of lead and lithium above specification.
Which Products Are Affected
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, NDC 42192-619-16. Affected lots are 23F02 (Expires: 05/2026) and 25A37 (Expires: 01/2028). A total of 6,336 bottles were distributed nationwide.
What You Should Do
Consumers should discontinue use of the affected product.
Why This Matters
This is an ongoing Class II recall involving a prescription drug distributed nationwide.
Source
FDA recall number D-0523-2026, report date 20260513.
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 (664 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.