Severity
Moderate
FDA Drug recall · Reported October 4, 2017
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Pfizer Inc. recalled Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospi… - a moderate-severity action.
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospi… was recalled by Pfizer Inc. in October 4, 2017. Reason: Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.. Check the official notice for the remedy. Verify recall #D-1177-2017 with the FDA Drug before acting.
The recall
Pfizer Inc. issued this moderate-severity FDA Drug recall-Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials..
Sourced from official FDA Drug enforcement records. Verify recall #D-1177-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1177-2017) was formally reported on October 4, 2017, with the manufacturer initiating the action on September 1, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Pfizer Inc. is listed as the recalling firm, operating out of New York, NY. Federal records list the affected scope as 18,725 vials.
The documented reason for this recall is: Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
18,725 vials
Related Recalls
6
5 from same agency
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1177-2017 |
| Date reported | October 4, 2017 |
| Date initiated | September 1, 2017 |
| Recalling firm | Pfizer Inc. |
| Firm location | New York, NY |
| Affected scope | 18,725 vials |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Lupin Pharmaceuticals Inc. · 2026-05-27
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 4, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.