FDA recall, , Moderate risk
Shoolin Pharma Chem Sildenafil Citrate and Tadalafil
Sildenafil citrate and tadalafil USP have CGMP deviations noted during FDA inspection.
Summary by Recall Canary from the FDA notice
What happened
Shoolin Pharma Chem LLP of Kadi, India, recalled Sildenafil Citrate USP and Tadalafil USP products due to CGMP deviations noted during an FDA inspection. The recall began August 3, 2026, and was added to the FDA's Enforcement Report on August 13, 2026. The products were distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
An NDC (National Drug Code) is usually printed on the drug's label.
Product details
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0)
- NDC
- 85702-001-05
- Lot code
- SDC2505001
Product details
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-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 1715996-29-5)
- NDC
- 85702-002-02
- Lot code
- TLF2506001
Product details
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. 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. 171599-83-0)
- NDC
- 85702-001-08
- Lot code
- SDC2505001
Product details
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
- Lot code
- TLF2506001
Product details
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-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
- 85702-001-08
- Lot code
- TLF2506001
Recall details
- Company began the recall
- Sold in
Distributed Nationwide in the USA
- Company
- Shoolin Pharma Chem LLPKadi, India
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99547
- Recall numbers
- D-0759-2026 to D-0763-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
