Hydroxyzine Hydrochloride Oral Solution Recall by ANI Pharmaceuticals
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ANI Pharmaceuticals, Inc. is recalling 6,564 bottles of hydroxyzine hydrochloride oral solution due to the presence of a foreign substance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 2026 and geographically references United States. Its severity classification of "low" 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
ANI Pharmaceuticals, Inc. initiated a voluntary recall of hydroxyzine hydrochloride oral solution due to the presence of a foreign substance.
Which Products Are Affected
The affected product is hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, NDC 70954-912-10, Lot S25133A. A total of 6,564 bottles are involved in the nationwide distribution in the USA. The recalling firm is ANI Pharmaceuticals, Inc., Baudette, MN.
What You Should Do
Consumers should follow guidance from the recalling firm regarding the affected lot.
Why This Matters
The Class III recall involves a product distributed nationwide that was found to contain a foreign substance.
Source
FDA recall number D-0619-2026, ANI Pharmaceuticals, Inc.
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 (780 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.