Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.500 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific hospitalization reports or structural defects typically fall into the High severity category, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Shoolin Pharma Chem LLP is recalling Tadalafil USP, 0.500 KG bags, NDC 85702-002-04. The product is intended for prescription compounding only and was distributed nationwide in the USA. The specific batch involved is TLF2506001, with an expiration date of May 31, 2028.
The recall was initiated because Current Good Manufacturing Practice (CGMP) deviations were noted during an FDA inspection. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- 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.
- 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 TLF2506001
- Date of Expiry: May 31
- 2028.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Shoolin Pharma Chem LLP
See all →- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate Recall Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- SevereShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
FDA (Drugs) · 2026-08-19
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- ModerateClomiphene Citrate USP Active Pharmaceutical Ingredient Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-15