CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Alprostadil Injection USP, 500 mg/mL single dose recalled
Teva Pharmaceuticals USA 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 USA, 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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 88442This product is part of a recall event; the main page for the event is Epoprostenol Sodium for Injection, 1.5 mg/vial vials recalled.
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Alprostadil recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalled | TMC Acquisition | Sterility | Nationwide |
| 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 25mcg/ML 25mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 32mcg/ML 32mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 30mcg/ML Inj 30mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |