Shoolin Pharma Chem Tadalafil Recall: FDA Inspection Findings
Shoolin Pharma Chem LLP recalls Tadalafil 100g bags due to FDA inspection finding CGMP deviations. Affected products have specific lot and expiry dates. Consumers should contact the manufacturer for details.
Recall notice
CGMP Deviations:Noted during FDA inspection
What happened, in plain English
Shoolin Pharma Chem LLP is recalling Tadalafil 100g bags (NDC 85702-002-02) because FDA inspections found quality control issues. This recall affects prescription compounding products with lot number TLF2506001 that expire May 31, 2028. Read more at govinfonow.com/recall/454400-shoolin-pharma-chem-tadalafil-recall-fda-inspection-findings.
Source Summary by GovInfoNow · govinfonow.com/recall/454400-shoolin-pharma-chem-tadalafil-recall-fda-inspection-findings · Updated August 27, 2026 · FDA enforcement record: FDA #D-0760-2026
Cite this page
“Shoolin Pharma Chem Tadalafil Recall: FDA Inspection Findings.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/454400-shoolin-pharma-chem-tadalafil-recall-fda-inspection-findings. Based on FDA recall #D-0760-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0760-2026%22&limit=1).
Why it’s dangerous
The FDA identified quality control deviations during an inspection. This means the medication may not meet safety and effectiveness standards, potentially leading to improper treatment outcomes. However, the specific nature of the deviations is not detailed in the recall notice.
Who’s affected
Prescription compounding pharmacies and healthcare providers using the Tadalafil 100g bags with lot number TLF2506001 are affected. Patients using these products under a prescription are at risk of receiving substandard medication.
How to tell if you have this one
Check for the lot number TLF2506001 on the packaging. The product is a 100g bag of Tadalafil (NDC 85702-002-02) that expires May 31, 2028, and is labeled for prescription compounding only.
- Brand
Shoolin Pharma Chem- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Distributed Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0759-2026 | 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; Batch SDC2505001, Date of Expiry: April 30, 2030. | 25KG, 250-1gm bags |
| D-0760-2026 | 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: TLF2506001, Date of Expiry: May 31, 2028. | 1KG - 100-0.1KG(100gm) bags |
| D-0761-2026 | 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.; Batch TLF2506001, Date of Expiry: May 31, 2028. | 20 KG, 40 X 0.500KG(500gm) bags |
| D-0762-2026 | 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; Batch TLF2506001, Date of Expiry: May 31, 2028. | 1KG - 20 X 1KG(1000gm) bags |
| D-0763-2026 | 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: SDC2505001, Date of Expiry: April 30, 2030. | 25 KG, 25 X 1.00 KG bags |
What to do — step by step
Check Product Details
Verify the lot number TLF2506001 and expiry date of May 31, 2028 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0760-2026 (August 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0760-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.