OVERLOOKED

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Class IIOngoing

Shoolin Pharma Chem LLP recalls 5 products

Recall date · record updated Aug 19, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Shoolin Pharma Chem LLP
Reason
CGMP Deviations:Noted during FDA inspection
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Distributed Nationwide in the USA
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99547…

Products (5)

  1. 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

    Codes/lots: Batch SDC2505001, Date of Expiry: April 30, 2030.Quantity: 25KG, 250-1gm bagsRecall no. D-0759-2026Class II

  2. 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.

    Codes/lots: Lot: TLF2506001, Date of Expiry: May 31, 2028.Quantity: 1KG - 100-0.1KG(100gm) bagsRecall no. D-0760-2026Class II

  3. 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.

    Codes/lots: Batch TLF2506001, Date of Expiry: May 31, 2028.Quantity: 20 KG, 40 X 0.500KG(500gm) bagsRecall no. D-0761-2026Class II

  4. 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

    Codes/lots: Batch TLF2506001, Date of Expiry: May 31, 2028.Quantity: 1KG - 20 X 1KG(1000gm) bagsRecall no. D-0762-2026Class II

  5. 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.

    Codes/lots: Lot: SDC2505001, Date of Expiry: April 30, 2030.Quantity: 25 KG, 25 X 1.00 KG bagsRecall no. D-0763-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

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Proof: raw official record (JSON) · fetched from FDA API

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