Injectable Tirzepatide-Niacinamide Compound Recalled for Lack of Manufacturing Controls
Aequita Pharmacy recalls 236 vials of compounded Tirzepatide-Niacinamide injectable due to lack of manufacturing process controls. Affected vials were distributed in Massachusetts.
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: FDA Class II recall of a sterile injectable product due to manufacturing control deficiencies. No illnesses or injuries are reported in the source text. Per the severity rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3 (High). This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Aequita Pharmacy, LLC (Kirkland, Washington) is recalling all lots of Tirzepatide + Niacinamide 2.2 mg + 1.0 mg/0.5 mL injectable solution that remain within their expiration date. A total of 236 vials have been distributed.
The recall is due to lack of adequate processing controls during manufacturing. This deficiency affects the company's ability to ensure the product meets required standards for sterility and quality as an injectable pharmaceutical.
The affected product was distributed in Massachusetts. Patients who have received this product should consult with their healthcare provider about whether they may be affected.
Any remaining vials should be returned to the dispensing pharmacy or manufacturer. Do not use any vials of this product.
The recalled product
- Product
- Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
- Manufacturer
- AEQUITA PHARMACY
- Category
- Drug — Injectable / Compounded
- Hazard
- manufacturing-defect
- sterility-risk
- contamination-risk
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 (1)
- All Lots within expiry
Distribution
Distributed in 1 state:
- MA
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27