Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall for a sterile injectable drug product with potential for serious health consequences if contaminated product is administered. Lack of sterility assurance in an injectable pharmaceutical meets the Severe criterion for injectable medications with potential for harm, even absent reported hospitalizations in the source text.
Plain-English summary
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in 1 mL single-dose vials (NDC 0703-0031-01), 5 mL multi-dose vials (NDC 0703-0043-01), and 10 mL multi-dose vials (NDC 0703-0045-01). The recall affects approximately 193,845 vials distributed nationwide, including Puerto Rico.
The reason for the recall is lack of assurance of sterility. The affected lot numbers are: 31328455B (exp. 09/2021), 31329340B (exp. 12/2021), 31329439B (exp. 01/2022), 31328347B (exp. 07/2021) for 1 mL vials; 31328321B (exp. 07/2021) for 5 mL vials; and 31328368B, 31328394B (exp. 07/2021), 31328699B (exp. 09/2021), 31328834B (exp. 10/2021), and 31329286B (exp. 12/2021) for 10 mL vials.
Healthcare providers and patients who have received this product should contact their pharmacy or healthcare provider for guidance. Patients should not stop using their medication without consulting their healthcare provider.
The recalled product
- Product
- 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.
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- lack-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
- 31328699B
- 31328834B
- exp. date 10/2021
- 31329286B
Distribution
Distributed nationwide across the United States.
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