Buspirone Hydrochloride Tablets Recall Issued by Unichem
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Unichem Pharmaceuticals USA Inc. is recalling 10,875 bottles of busPIRone Hydrochloride Tablets, USP 5 mg due to subpotent drug.
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 "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
Unichem Pharmaceuticals USA Inc. initiated a voluntary recall of busPIRone Hydrochloride Tablets because the product is subpotent.
Which Products Are Affected
The recall covers busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only (NDC 29300-244-05), Lot ZBUL25001 with expiration date 12/31/2027. A total of 10,875 bottles are affected and were distributed nationwide in the United States.
What You Should Do
Consumers should contact their healthcare provider or pharmacist regarding the recalled product.
Why This Matters
The recall addresses a subpotent drug distributed across the United States.
Source
FDA recall number D-0511-2026, Unichem Pharmaceuticals (USA), 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 (722 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to May 24, 2026.
Frequently Asked Questions
Common questions about this FDA recall.