Shoolin Pharma Chem LLP Sildenafil Citrate USP, 1.00KG, 1.00KG-bag recall: CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
The hazard: Labelling or manufacturing-practice failure
The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.
What the notice says: CGMP Deviations:Noted during FDA inspection
Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.
Symptoms and when to call a doctor
If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- D-0763-2026
- Published
- August 19, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Shoolin Pharma Chem LLP
- Product type
- Prescription & OTC drugs
- Units affected
- 25 KG, 25 X 1.00 KG bags
- Distribution
- Nationwide
- Made in
- India
- Lot / code info
- Lot: SDC2505001, Date of Expiry: April 30, 2030.
Products covered by this recall
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.
Check your product
The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- SDC2505001
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- April 30
- 2030. — 25 KG
NDC number
On the carton and again on the bottle or blister label.
- 85702-001-08
Package size
Match the net weight or the piece count on the front of the pack.
- 1.00 KG
- 25 KG
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Labelling
Shoolin Pharma Chem LLP — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.
- Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
- Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
- If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
- Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: Shoolin Pharma Chem LLP — 408 B/H Ratnamani Tubes, Kadi
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Shoolin Pharma Chem LLP prescription & otc drugs recalled?
CGMP Deviations:Noted during FDA inspection CGMP Deviations:Noted during FDA inspection
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code SDC2505001; best-by date April 30 or 2030. — 25 KG. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · 2 months ago
Shoolin Pharma Chem LLP Sildenafil Citrate USP, 0.100 KG, 100 gm-bag recall: CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
-
Class II · 2 months ago
Shoolin Pharma Chem LLP Tadalafil USP, 0.100 KG, 0.1KG -bag recall: CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
-
Class II · 2 months ago
Shoolin Pharma Chem LLP Tadalafil USP, 0.500 KG, 0.500KG -bag recall: CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
-
Class II · 2 months ago
Shoolin Pharma Chem LLP Tadalafil USP, 1.00 KG, 1KG -bag recall: CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
-
Class II · 11 days ago
K.C. Pharmaceuticals, Inc. Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
-
Class II · 11 days ago
Carolina Infusion, LLC Quad-Mix Injectable, Packaged in single-use dosage syringes recall: Lack of Assurance of Sterility: Related to processing equipment used
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.