CLASS II Drug recall · Reported 26 May 2021 · FDA Enforcement Report
Haloperidol Decanoate Injection, USP 50 mg/mL Single Dose Vials recalled
Teva Pharmaceuticals U is recalling Haloperidol Decanoate Injection, USP 50 mg/mL Single Dose Vials, distributed nationwide in the US. The recall was initiated on 26 Apr 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-0375-2021
- FDA event ID
- 87875
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2021
- FDA classified
- 14 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Apr 2021 | Recall initiated by company | |
| 14 May 2021 | Classified by FDA | +18 days |
| 26 May 2021 | Published in enforcement report | +12 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
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Is Haloperidol Decanoate Injection, USP 50 mg/mL Single Dose Vials recalled?
Yes. Teva Pharmaceuticals U recalled Haloperidol Decanoate Injection, USP 50 mg/mL Single Dose Vials on 26 Apr 2021. The recall is Class II and its status is Terminated. Recall number D-0375-2021.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # 31325793C, exp. date 09/2021
Where was it sold?
Product was distributed nationwide.
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.
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Other Haloperidol decanoate recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Haloperidol Decanoate Injection, 50mg/mL* Single-Dose Vial recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection, 100mg/mL*, mL Single-Dose Vials recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection, 100 mg/mL*, mL Single-Dose Vial recalledHaloperidol Decanoate | Amerisource Health Services | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection 100mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |
| Drug | CLASS II | Haloperidol Decanoate Injection 50mg/mL Single-Dose Vial recalledHaloperidol Decanoate | Somerset Therapeutics Private | Sterility | Nationwide |