Ampicillin for Injection Recalled for Lack of Sterility Assurance
Piramal Critical Care is recalling Ampicillin for Injection nationwide due to lack of sterility assurance. Approximately 8,925 bottles are affected.
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 injectable medication for which sterility cannot be assured. No illnesses or injuries have been reported. The theoretical risk posed by potential contamination in an injectable product warrants a High severity rating.
Plain-English summary
Piramal Critical Care is recalling Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package (NDC 66794-224-15), manufactured by Astral SteriTech Private Ltd. All lots within their expiry dates are included in this nationwide recall.
The manufacturer cannot assure the sterility of the product. If the product is contaminated, patients who receive the medication could be at risk for serious infections.
Approximately 8,925 bottles have been distributed nationwide within the United States.
Patients who have received this product should contact their healthcare provider or pharmacist immediately. Healthcare facilities should quarantine the affected product and return it to the supplier.
The recalled product
- Product
- Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- 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 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