CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Alprostadil Injection USP, 500 mg/mL single dose recalled
Teva Pharmaceuticals U is recalling Alprostadil Injection USP, 500 mg/mL single dose, vials single use vial per carton (, distributed nationwide in the US. The recall was initiated on 29 Jul 2021 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-0742-2021
- FDA event ID
- 88442
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 16 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 16 Aug 2021 | Classified by FDA | +18 days |
| 25 Aug 2021 | Published in enforcement report | +9 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
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Where it was distributed
Product was distributed Nationwide, including Puerto Rico.
Questions about this recall
Is Alprostadil Injection USP, 500 mg/mL single dose, vials single use vial per carton ( recalled?
Yes. Teva Pharmaceuticals U recalled Alprostadil Injection USP, 500 mg/mL single dose, vials single use vial per carton ( on 29 Jul 2021. The recall is Class II and its status is Terminated. Recall number D-0742-2021.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 31329295B, exp date. 01/2022
Where was it sold?
Product was distributed Nationwide, including Puerto Rico.
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.
More recalls from Teva Pharmaceuticals U
All 196| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS II | Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Packaging Defects | Nationwide |
Other Alprostadil recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Alprostadil Injection USP 500 micrograms/mL single use vial recalled | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Edex (alprostadil for injection) 10mcg recalled by Endo PharmaceuticalsEdex | Endo Pharmaceuticals | Sterility | Nationwide |