The South African Health Products Regulatory Authority (SAHPRA) has initiated a Class I – Type A recall of Semaglutide, Tirzepatide, and Semaglutide/Tirzepatide Combination products compounded by iDEXIS (Pty) Ltd Sentra Pharmacy. The recall, announced following an inspection on May 11, 2026, stems from potential serious safety concerns. SAHPRA, jointly with SAPC, conducted an investigation at iDEXIS (Pty) Ltd Sentra Pharmacy, located at 521 Moreleta Street, Silverton, Pretoria, 0187. Regulators seized the compounded products onsite and resolved to recall all affected batches currently in the market. The recall applies to all distributed products containing Semaglutide, Tirzepatide, or their combination from iDexis (Pty) Ltd Sentra Pharmacy.
Specific Products Affected
The recall initiated by the South African Health Products Regulatory Authority (SAHPRA) encompasses multiple batches of compounded weight-loss drugs. Among the Tirzepatide products affected are the 15 mg pen (Batch number P2600170, Expiry Date 09/2026, Pack Size 2.4ml), the 10 mg pen (Batch number P2600169, Expiry Date 09/2026, Pack Size 2.4ml), and two batches of the 5 mg pen (Batch number P2600175 with Expiry Date 09/2026, and Batch number P2600175 with Expiry Date 03/2026), all in 2.4ml pack sizes. Each of these Tirzepatide products is classified as a Class I Type A recall.
The Semaglutide products subject to recall include the 2 mg pen (Batch number P2600151, Expiry Date 09/2026, Pack Size 2.4ml), the 1 mg pen (Batch number P2600161, Expiry Date 09/2026, Pack Size 2.4ml), and the 0.5 mg pen (Batch number P2600153, Expiry Date 09/2026, Pack Size 2.4ml). These are also designated as Class I Type A recalls.
Combination products are also part of the recall. These include the Semaglutide 0.5 mg Tirzepatide 5 mg pen (Batch number P2600135, Expiry Date 09/2026, Pack Size 2.4ml), and the Semaglutide 2 mg Tirzepatide 15 mg pen (Batch number P2600190, Expiry Date 10/2026, Pack Size 2.4ml). Several batches of the Semaglutide 2 mg Tirzepatide 15 mg cartridge are also recalled: Batch number P2600183 (Expiry Date 09/2026, Pack Size 2.4ml), Batch number P2600161 (Expiry Date 09/2026, Pack Size 2.4ml), and Batch number P2600190 (Expiry Date 09/2026, Pack Size 2.4ml). All combination products are similarly categorized as Class I Type A recalls.
Action for Public and Professionals
Pharmacies, medical doctors, and patients in possession of any Semaglutide, Tirzepatide, or Semaglutide/Tirzepatide Combination products have been instructed to cease their use and sale immediately. These products, which are subject to the recall, must be returned to the pharmacy or healthcare professional from whom they were dispensed without delay. Sentra Pharmacy, trading as iDexis (Pty) Ltd, will manage the collection of all recalled stock. The company has also confirmed that it will arrange for reimbursement for the returned products. For further inquiries regarding the recall or stock collection, iDexis (Pty) Ltd, trading as Sentra Pharmacy, can be contacted at +27 12 804 455.
Reporting Side Effects
Public and healthcare professionals are encouraged to report any side effects experienced from these products. The South African Health Products Regulatory Authority (SAHPRA) has advised individuals to use the Med Safety App for submitting such reports. This reporting mechanism is vital for monitoring adverse reactions and ensuring public health safety.
