Shoolin Pharma Chem LLP recall: Sildenafil Citrate Usp and 1 more product
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate Usp and 1 more product because of manufacturing-practice violations – 25KG, 250-1gm bags; 1KG - 100-0.1KG(100gm) bags; 20 KG, 40 X 0.500KG(500gm) bags; 1KG - 20 X 1KG(1000gm) bags; 25 KG, 25 X 1.00 KG bags. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on August 3, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Share
| Product | Sildenafil Citrate Usp and 1 more product |
| Brand | Shoolin Pharma Chem LLP |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 3, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 25KG, 250-1gm bags; 1KG - 100-0.1KG(100gm) bags; 20 KG, 40 X 0.500KG(500gm) bags; 1KG - 20 X 1KG(1000gm) bags; 25 KG, 25 X 1.00 KG bags |
| Recall ID | 99547 |
Recalled products (5)
- 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
- FDA recall number
- D-0759-2026
- Codes, lots and dates
- Batch SDC2505001, Date of Expiry: April 30, 2030.
- Quantity
- 25KG, 250-1gm bags
- Classification
- Class II
- TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.
- FDA recall number
- D-0760-2026
- Codes, lots and dates
- Lot: TLF2506001, Date of Expiry: May 31, 2028.
- Quantity
- 1KG - 100-0.1KG(100gm) bags
- Classification
- Class II
- TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
- FDA recall number
- D-0761-2026
- Codes, lots and dates
- Batch TLF2506001, Date of Expiry: May 31, 2028.
- Quantity
- 20 KG, 40 X 0.500KG(500gm) bags
- Classification
- Class II
- TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
- FDA recall number
- D-0762-2026
- Codes, lots and dates
- Batch TLF2506001, Date of Expiry: May 31, 2028.
- Quantity
- 1KG - 20 X 1KG(1000gm) bags
- Classification
- Class II
- SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-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, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
- FDA recall number
- D-0763-2026
- Codes, lots and dates
- Lot: SDC2505001, Date of Expiry: April 30, 2030.
- Quantity
- 25 KG, 25 X 1.00 KG bags
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99547
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Kadi, India
Why it was recalled
The problem: manufacturing-practice violations.
The reason the FDA lists: “CGMP Deviations:Noted during FDA inspection”
Where it was sold
Nationwide. Distribution as the FDA records it: “Distributed Nationwide in the USA”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99547, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Shoolin Pharma Chem LLP Sildenafil Citrate Usp recalled?
Yes. Shoolin Pharma Chem LLP recalled it on August 3, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of manufacturing-practice violations. The reason given: CGMP Deviations:Noted during FDA inspection
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.