Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the company cannot guarantee the product is sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension, 50 mg/mL, 10 mL multi-dose vials. The recall was initiated because the manufacturer lacks assurance of the sterility of the affected product.
The affected product is distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic. The specific lots subject to the recall are 03202019+51817 (Exp 4/16/2020), 09122019+52911 (Exp 10/9/2020), and 09132019+52918 (Exp 8/12/2020).
Healthcare providers and patients should discontinue use of the affected lots and contact the manufacturer for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0636-1
- Category
- Drug — Injectable Steroid
- Hazard
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 (6)
- Lot #: 03202019+51817
- Exp 4/16/2020
- 09122019+52911
- Exp 10/9/2020
- 09132019+52918
- Exp 8/12/2020
Distribution
Part of a larger recall action
This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 63 products in this recall →Related recalls
Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
See all →- SevereAxia Pharmaceutical Recalls Selenium Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- Severe
- SevereAxia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- SevereAxia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- SevereAxia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereTeva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns
FDA (Drugs) · 2021-05-26
- SevereMethylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance
FDA (Drugs) · 2021-08-25
- SevereMethylprednisolone Acetate Injectable Suspension recalled for sterility concerns
FDA (Drugs) · 2021-08-25
- SevereMethylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance
FDA (Drugs) · 2022-01-19
- SevereIsomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns
FDA (Drugs) · 2017-05-03
- SevereMethylprednisolone Acetate Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2013-05-01