Astral SteriTech Private Ltd.

Astral SteriTech Private Ltd.: 52 FDA recall reports

Every drug recall the FDA has published for Astral SteriTech Private Ltd.. The fault, and how the agency graded it.

52Reports
0Class I
0Ongoing
2023-05-24Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II52
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals C

D-0625-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
Where it went
Nationwide within the United States
How much
249,080 vials

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chic

D-0592-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
Where it went
Nationwide within the United States
How much
236,610 vials

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceu

D-0620-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01
Where it went
Nationwide within the United States
How much
7,940 bottles

Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care

D-0627-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
Where it went
Nationwide within the United States
How much
223,590 vials

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicag

D-0593-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
Where it went
Nationwide within the United States
How much
1,229,090 vials

Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem

D-0600-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
Where it went
Nationwide within the United States
How much
91,860 vials

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017,

D-0612-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
Where it went
Nationwide within the United States
How much
65,950 vials

Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care,

D-0626-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
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
Where it went
Nationwide within the United States
How much
112,640 vials

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Beth

D-0595-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41
Where it went
Nationwide within the United States
How much
357,550 vials

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buff

D-0610-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02
Where it went
Nationwide within the United States
How much
964,420 vials

Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA,

D-0583-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
Where it went
Nationwide within the United States
How much
45,160 vials

Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuti

D-0629-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02
Where it went
Nationwide within the United States
How much
169,520 Vials

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Beth

D-0596-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
Where it went
Nationwide within the United States
How much
58,770 vials

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmace

D-0631-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02
Where it went
Nationwide within the United States
How much
393,930 vials

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Cri

D-0599-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15
Where it went
Nationwide within the United States
How much
6,127 bottles

Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017,

D-0613-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
Where it went
Nationwide within the United States
How much
73,475 vials

Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo

D-0587-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
Where it went
Nationwide within the United States
How much
80,850 vials

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Leh

D-0622-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
Where it went
Nationwide within the United States
How much
204,860 vials

Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA,

D-0607-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
Where it went
Nationwide within the United States
How much
41,320 vials

Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove,

D-0609-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
Where it went
Nationwide within the United States
How much
550,160 vials

Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffal

D-0588-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02
Where it went
Nationwide within the United States
How much
220,340 vials

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 7257

D-0605-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
Where it went
Nationwide within the United States
How much
124,010 vials

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Cri

D-0598-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
Where it went
Nationwide within the United States
How much
11,555 bottles

Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah

D-0591-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
Where it went
Nationwide within the United States
How much
419,680 vials

Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, ND

D-0606-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
Where it went
Nationwide within the United States
How much
107,320 vials

Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buf

D-0586-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
Where it went
Nationwide within the United States
How much
59,530 vials

Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. L

D-0621-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
Where it went
Nationwide within the United States
How much
1,288,510 vials

Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethle

D-0584-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
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
Where it went
Nationwide within the United States
How much
8,925 bottles

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethle

D-0597-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
Where it went
Nationwide within the United States
How much
1,001,110 vials

Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharma

D-0630-2023  ·  Class II  ·  reported 2023-05-24  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02
Where it went
Nationwide within the United States
How much
936,680 vials

Showing the 30 most recent of 52. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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