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Recalls Watch

FDA recall 99547: Shoolin Pharma Chem LLP: SILDENAFIL CITRATE USP and 4 more

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FDARecall 99547Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

Why it was recalled

CGMP Deviations:Noted during FDA inspection
Text from FDA, unedited.

FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.

Is it yours? Products and codes

  • 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 or code
    Batch SDC2505001, Date of Expiry: April 30, 2030.
    FDA recall number
    D-0759-2026
    Quantity
    25KG, 250-1gm bags

  • 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 or code
    Lot: TLF2506001, Date of Expiry: May 31, 2028.
    FDA recall number
    D-0760-2026
    Quantity
    1KG - 100-0.1KG(100gm) bags

  • 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 or code
    Batch TLF2506001, Date of Expiry: May 31, 2028.
    FDA recall number
    D-0761-2026
    Quantity
    20 KG, 40 X 0.500KG(500gm) bags

  • 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 or code
    Batch TLF2506001, Date of Expiry: May 31, 2028.
    FDA recall number
    D-0762-2026
    Quantity
    1KG - 20 X 1KG(1000gm) bags

  • 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 or code
    Lot: SDC2505001, Date of Expiry: April 30, 2030.
    FDA recall number
    D-0763-2026
    Quantity
    25 KG, 25 X 1.00 KG bags

Distribution (FDA): Distributed Nationwide in the USA

About this record

Issued by
U.S. Food and Drug Administration
Firm
Shoolin Pharma Chem LLP
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

About this recall

What is the hazard?

FDA states: “CGMP Deviations:Noted during FDA inspection”

What should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

When was this recall published?

FDA published recall 99547 on August 19, 2026.

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