Unichem Pharmaceuticals USA Inc. recalls busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind,…
- Recall date
- April 13, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0511-2026
- FDA classification
- Class III
- Brand / firm
- Unichem Pharmaceuticals USA Inc.
- Sold / distributed
- USA Nationwide
Why it was recalled
Subpotent drug
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
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