The FDA classified as Class II, on 19 August 2026, an ongoing recall of tadalafil USP supplied in 100 g, 500 g and 1 kg bags by Shoolin Pharma Chem LLP, labelled for prescription compounding only. The reason recorded is deviation from current good manufacturing practice, identified during an FDA inspection. Sildenafil citrate from the same supplier is covered by the same action.
The distinction that matters is between bulk drug substance and finished product. This is raw material sold to compounding pharmacies; licensed tadalafil tablets are not within the recall, and a man on a proprietary or generic tablet needs no action. Class II means exposure may cause temporary or medically reversible harm with serious injury unlikely, and a manufacturing practice deviation found at inspection describes a failure of process control rather than a defect identified in a particular batch.
For a urologist the relevant exposure is broader than erectile dysfunction. Tadalafil 5 mg daily is a licensed treatment for lower urinary tract symptoms from benign prostatic hyperplasia, and compounded formulations are used where a patient cannot take a tablet or where a combination preparation has been prescribed. So the question to ask is not only about erectile dysfunction prescribing but about any man on a compounded tadalafil preparation for LUTS. The record covers a US enforcement action; it makes no statement about supply in other markets, and the CDSCO position on this material is not addressed in it.
- Licensed tadalafil tablets are unaffected — only bulk substance for compounding is recalled.
- Ask specifically about compounded preparations in men taking daily tadalafil for LUTS, not just for erectile dysfunction.
- Class II describes a process control failure found at inspection, not a defect found in a dose.
- Prefer a licensed finished product wherever a compounded formulation is not clinically necessary.
- The action is a US recall and says nothing about supply elsewhere.
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