CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL recalled
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 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-0731-2021
- 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
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
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 #: a) 31328455B, exp. date 09/2021; 31329340B, exp. date 12/2021; 31329439B, exp. date 01/2022; 31328347B, exp. date 07/2021 b) 31328321B, exp. date 07/2021; c) 31328368B, 31328394B, exp. date 07/2021; 31328699B, exp. date 09/2021; 31328834B, exp. date 10/2021; 31329286B, exp. date 12/2021
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 Methylprednisolone recalls
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate | Eugia US | Potency & Assay | 4 states |
| Drug | CLASS III | Methylprednisolone Acetate Injectable Suspension recalled | Amneal Pharmaceuticals of New York | Packaging Defects | Nationwide |
| Drug | CLASS II | Methylprednisolone 12MG IN NS Syringe, steroid recalled | Sentara Infusion Services | Sterility | Nationwide |