Piperacillin and Tazobactam Injectable: Lack of Sterility Assurance Recall
Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, due to lack of sterility assurance. The nationwide recall affects approximately 112,640 vials.
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 injectable pharmaceutical recall. The product lacks sterility assurance, creating potential for serious infection if contaminated. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, supporting a High severity classification per the rubric.
Plain-English summary
Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial (NDC 66794-216-41), manufactured by Astral SteriTech Private Ltd. The product is an injectable antibiotic combination used in clinical settings.
The recall is due to lack of assurance of sterility. The manufacturer cannot confirm that the product meets required sterility standards, a fundamental safety requirement for injectable medications.
The affected product was distributed nationwide within the United States. Approximately 112,640 vials are included in the recall, encompassing all lots within their expiration date.
Healthcare providers should verify inventory of this product. Patients should consult their healthcare provider regarding any medication received during the recall period.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- lack-of-sterility-assurance
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 nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27