Shoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
Shoolin Pharma Chem LLP is recalling Tadalafil USP 0.100 KG bags due to Current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection.
What this means for you
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 or injuries, fitting the criteria for a moderate severity recall involving manufacturing deviations without confirmed harm.
Plain-English summary
Shoolin Pharma Chem LLP is recalling Tadalafil USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only". The product is identified by Lot TLF2506001 and has 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 affected product is distributed nationwide in the USA. It is intended for prescription compounding only. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- 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.
- 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)
- Lot: TLF2506001
- Date of Expiry: May 31
- 2028.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Shoolin Pharma Chem LLP
See all →- HighShoolin 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