CLASS III Drug recall · Reported 15 Jun 2022 · FDA Enforcement Report
Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials recalled
Teva Pharmaceuticals USA is recalling Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials per, distributed nationwide in the US. The recall was initiated on 18 May 2022 and the FDA has classified it as Class III.
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-0988-2022
- FDA event ID
- 90239
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 May 2022
- FDA classified
- 7 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 18 May 2022 | Recall initiated by company | |
| 7 Jun 2022 | Classified by FDA | +20 days |
| 15 Jun 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
Where it was distributed
Product was distributed nationwide in the US Market
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Which lots are affected?
Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
Where was it sold?
Product was distributed nationwide in the US Market
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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 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 |
| Drug | CLASS II | Alprostadil 45mcg/ML 45mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |