CLASS II Drug recall · Reported 6 Jan 2016 · FDA Enforcement Report
Folic Acid 1 mg/ syringe recalled by Walgreens Infusion Services
Walgreens Infusion Services is recalling Folic Acid 1 mg/ syringe, distributed in Texas. The recall was initiated on 10 Nov 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0543-2016
- FDA event ID
- 72594
- Recalling firm
- Walgreens Infusion Services, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2015
- FDA classified
- 30 Dec 2015
- Reported
- 6 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 10 Nov 2015 | Recall initiated by company | |
| 30 Dec 2015 | Classified by FDA | +50 days |
| 6 Jan 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Where it was distributed
Texas
Stores named: Walgreens
Questions about this recall
Is Folic Acid 1 mg/ syringe recalled?
Yes. Walgreens Infusion Services recalled Folic Acid 1 mg/ syringe on 10 Nov 2015. The recall is Class II and its status is Terminated. Recall number D-0543-2016.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lots within expiry.
Where was it sold?
Texas
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.