Ampicillin for Injection Recall Due to Sterility Assurance Concerns
Astral SteriTech is recalling 70,040 vials of Ampicillin for Injection nationwide due to lack of assurance of sterility in the manufacturing process.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—lack of assurance of sterility—is theoretical and preventive in nature. Per the severity rubric, recalls with theoretical, unconfirmed hazards and no reported harm are rated High (3).
Plain-English summary
Astral SteriTech Private Ltd. is recalling 70,040 vials of Ampicillin for Injection, USP 250 mg per vial (NDC 66794-220-41), manufactured for Piramal Critical Care. The recall was initiated due to lack of assurance of sterility.
Sterility is a critical quality attribute for injectable medications. An injectable product that is not sterile could introduce bacteria or other microorganisms into the bloodstream. All affected lots remain within their expiration dates.
The recalled product was distributed nationwide within the United States. Healthcare providers and patients who have received or possess this medication should consult with their healthcare provider or pharmacist regarding appropriate action.
Consumers with questions or who believe they have received the recalled product should contact their healthcare provider, pharmacist, or the manufacturer. Healthcare facilities should verify whether they received the recalled lots and quarantine any affected inventory.
The recalled product
- Product
- Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 70,040
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.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 52 products in this recall →Related recalls
Same manufacturer · Astral SteriTech Private Ltd.
See all →- HighCeftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-05-24
- HighCeftriaxone Injectable Antibiotic Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-24
- HighAmpicillin and Sulbactam Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-05-24
- HighPiperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-05-24
- HighPiperacillin and Tazobactam Injection Recalled Due to Sterility Assurance Issue
FDA (Drugs) · 2023-05-24
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighNafcillin for Injection recalled nationwide for lack of sterility assurance
FDA (Drugs) · 2023-05-31
- HighOxacillin Injectable Recalled for Failure to Assure Sterility
FDA (Drugs) · 2023-08-02
- HighAmpicillin Injectable Solution Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighAmpicillin IV Infusion Bags Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- SevereAlvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2017-07-12
- HighOxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-02