Tadalafil USP Recall Issued by Shoolin Pharma Chem
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Shoolin Pharma Chem LLP is recalling Tadalafil USP due to CGMP deviations identified during an FDA inspection.
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 Tadalafil USP because of CGMP deviations noted during an FDA inspection.
Which Products Are Affected
The recall involves TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", NDC 85702-002-04. Affected batch is TLF2506001 with expiration date May 31, 2028. A total of 20 KG (40 X 0.500KG(500gm) bags) were distributed nationwide in the USA. The recalling firm is located in Kadi, India.
What You Should Do
Consumers should contact the recalling firm regarding returns or refunds. The recall number is D-0761-2026.
Why This Matters
The Class II recall affects a prescription compounding ingredient distributed across the United States.
Source
FDA Recall D-0761-2026 - Shoolin Pharma Chem LLP
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 (820 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.