CLASS II ONGOING Drug recall · Reported 19 Aug 2026 · FDA Enforcement Report
Tadalafil USP(500gm)-bag recalled by Shoolin Pharma Chem L
Shoolin Pharma Chem is recalling Tadalafil USP(500gm)-bag, distributed nationwide in the US. The recall was initiated on 3 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0761-2026
- FDA event ID
- 99547
- Recalling firm
- Shoolin Pharma Chem, Kadi
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Aug 2026
- FDA classified
- 13 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Compounded Drugs
Timeline
| 3 Aug 2026 | Recall initiated by company | |
| 13 Aug 2026 | Classified by FDA | +10 days |
| 19 Aug 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations:Noted during FDA inspection
Product as listed by the FDA
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations:Noted during FDA inspection
Which lots are affected?
Batch TLF2506001, Date of Expiry: May 31, 2028.
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 99547This product is part of a recall event; the main page for the event is Sildenafil Citrate USP, 100 gm recalled by Shoolin Pharma Chem L.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sildenafil Citrate USP, 100 gm recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Tadalafil USP(100gm)-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Sildenafil Citrate recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Tadalafil USP(1000gm)-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Shoolin Pharma Chem
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tadalafil USP(1000gm)-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sildenafil Citrate recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil USP(100gm)-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sildenafil Citrate USP, 100 gm recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem | Manufacturing (CGMP) Deviations | Nationwide |