Sildenafil Citrate USP Recall Issued by Shoolin Pharma Chem
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Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP due to CGMP deviations identified during an FDA inspection. The Class II recall affects product distributed nationwide in the USA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 25, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP because of CGMP deviations noted during an FDA inspection.
Which Products Are Affected
The recall covers SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", manufactured by Shoolin Pharma Chem LLP in Kadi, India. Affected product includes 25KG total (250-1gm bags) under batch SDC2505001 with expiration date April 30, 2030. NDC 85702-001-05. Recall number D-0759-2026. Distributed nationwide in the USA.
What You Should Do
Consumers and compounding facilities should follow guidance from the recalling firm regarding the affected batch.
Why This Matters
This ongoing Class II recall involves a prescription compounding ingredient distributed across the United States.
Source
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts (Recall D-0759-2026, FDA)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (908 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 25, 2026.
Frequently Asked Questions
Common questions about this FDA recall.