Sildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or specific contamination hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only". The product is identified by Batch SDC2505001 and has an expiration date of April 30, 2030. The recall was initiated because Current Good Manufacturing Practice (CGMP) deviations were noted during an FDA inspection.
The affected product was distributed nationwide in the USA. The source text does not specify the exact number of units recalled or the specific pharmacies or compounding facilities that received the product.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns. The source text does not provide specific instructions for disposal or return logistics beyond the standard recall notification.
The recalled product
- Product
- 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
- Manufacturer
- Shoolin Pharma Chem LLP
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch SDC2505001
- Date of Expiry: April 30
- 2030.
Distribution
Distributed nationwide across the United States.
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