SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LL
Summary
The FDA issued a Class II for SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription C by Shoolin Pharma Chem LLP. Reason: CGMP Deviations:Noted during FDA inspection.
Details
Source
Drug Recall
External ID
D-0759-2026
Action Date
2026-08-19
Status
Ongoing
Category
drug
Product Description
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 Info: Batch SDC2505001, Date of Expiry: April 30, 2030.
Quantity Affected: 25KG, 250-1gm bags
Reason for Recall
CGMP Deviations:Noted during FDA inspection
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-03
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 28 drug recalls issued in the same week, part of 68 drug-related FDA actions this month.
Shoolin Pharma Chem LLP has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shoolin Pharma Chem LLP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shoolin Pharma Chem LLP have FDA actions?
Shoolin Pharma Chem LLP has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0759-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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