Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported November 25, 2020
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Hikma Pharmaceuticals USA Inc. recalled Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative… - a moderate-severity action.
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative… was recalled by Hikma Pharmaceuticals USA Inc. in November 25, 2020. Reason: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.…. Check the official notice for the remedy. Verify recall #D-0101-2021 with the FDA Drug before acting.
The recall
Hikma Pharmaceuticals USA Inc. issued this moderate-severity FDA Drug recall-Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.….
- Moderate
- severity level
- Class II
- classification
- November 25, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0101-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0101-2021) was formally reported on November 25, 2020, with the manufacturer initiating the action on November 3, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Hikma Pharmaceuticals USA Inc. is listed as the recalling firm, operating out of Cherry Hill, NJ. Federal records list the affected scope as 2,100,646 Vials.
The documented reason for this recall is: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial. Distribution data in the federal record shows the product reached: Nationwide in the U.S.. 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.
Drugs & Medications recalls over time
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.
Affected scope
2,100,646 Vials
Related Recalls
6
5 from same agency
Product description
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
Reason for recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0101-2021 |
| Date reported | November 25, 2020 |
| Date initiated | November 3, 2020 |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Firm location | Cherry Hill, NJ |
| Affected scope | 2,100,646 Vials |
| Distribution | Nationwide in the U.S. |
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.
- Check the recall number (D-0101-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 2,100,646 Vials.
Why was this product recalled? ▼
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2020. Severity: Moderate. Recall number: D-0101-2021.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the U.S..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0101-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 November 25, 2020. 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.