FDA Drug recall · Reported August 19, 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
CGMP Deviations:Noted during FDA inspection
Shoolin Pharma Chem LLP recalled SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compoundin… - a moderate-severity action.
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compoundin… was recalled by Shoolin Pharma Chem LLP in August 19, 2026. Reason: CGMP Deviations:Noted during FDA inspection. Check the official notice for the remedy. Verify recall #D-0759-2026 with the FDA Drug before acting.
The recall
Shoolin Pharma Chem LLP issued this moderate-severity FDA Drug recall-CGMP Deviations:Noted during FDA inspection.
- Moderate
- severity level
- Class II
- classification
- August 19, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0759-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0759-2026) was formally reported on August 19, 2026, with the manufacturer initiating the action on August 3, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Shoolin Pharma Chem LLP is listed as the recalling firm, operating out of Kadi. Federal records list the affected scope as 25KG, 250-1gm bags.
The documented reason for this recall is: CGMP Deviations:Noted during FDA inspection Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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
Reason for recall
CGMP Deviations:Noted during FDA inspection
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0759-2026 |
| Date reported | August 19, 2026 |
| Date initiated | August 3, 2026 |
| Recalling firm | Shoolin Pharma Chem LLP |
| Firm location | Kadi |
| Affected scope | 25KG, 250-1gm bags |
| Distribution | Distributed Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0759-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
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Methodology · Corrections · Archive as of August 2026