Unrated Drug recall · FDA · Published December 31, 2021

Teva Methylprednisolone Acetate Injectable Suspension Recall: Lack of Sterility Assurance

Teva Pharmaceuticals USA recalls 10mL multiple-dose vials of Methylprednisolone Acetate Injectable Suspension due to lack of sterility assurance. This could lead to infections if used improperly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0370-2022Drug Teva Pharmaceuticals USA ›

Recall notice

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmTeva Pharmaceuticals USA400 Interpace Pkwy · Parsippany, NJ 07054-1120

✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals USA is recalling a specific injectable steroid medication because it may not be sterile. Using this product could lead to infections, especially in medical settings where sterility is critical. Read more at govinfonow.com/recall/35408-teva-methylprednisolone-acetate-injectable-suspension-recall-lack-of-sterility-assurance.

Source Summary by GovInfoNow · govinfonow.com/recall/35408-teva-methylprednisolone-acetate-injectable-suspension-recall-lack-of-sterility-assurance · Updated August 18, 2026 · FDA enforcement record: FDA #D-0370-2022

Cite this page

“Teva Methylprednisolone Acetate Injectable Suspension Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35408-teva-methylprednisolone-acetate-injectable-suspension-recall-lack-of-sterility-assurance. Based on FDA recall #D-0370-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0370-2022%22&limit=1).

The FDA announced on 2021-12-31 that Teva Pharmaceuticals USA voluntarily recalled MethylPREDNISolone Acetate Injectable Suspension USP due to a lack of assurance of sterility, according to the FDA.

How to tell if you have it

Brand: Teva Pharmaceuticals USA
Product: MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only
NDC: 16714-090-01
Lot #: 100022393
Expiration: 09/2022
Quantity: 7,400 cartons

The hazard

The recall addresses a lack of assurance of sterility in the product, according to the FDA.

Context

GovInfoNow's records show Teva Pharmaceuticals USA has 97 other recalls on record since 2013-10-11. Other recent recalls include the 2022-01-18 Teva Doxylamine Succinate Tablets Recall, the 2022-01-10 Teva Tretinoin Capsules 10mg Recall, and the 2022-01-07 Teva Mimvey Tablets Recall. Similar recent recalls of similar products include the 2026-04-24 Teva Octreotide Acetate 30mg Kit recall, the 2026-03-17 Teva Octreotide Acetate 20mg Vial Recall, and the 2026-03-17 Teva Octreotide Acetate 10mg Vial Recall.

How to tell if you have this one

Check for the product name 'Methylprednisolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL)', 10 mL Multiple-Dose Vial, Rx Only. Look for lot number 100022393 with expiration date 09/2022.

Brand
Teva Pharmaceuticals USA
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

Recall number	Product, codes & lots	Quantity
D-0370-2022	MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.; Lot # 100022393, exp 09/2022	7,400 cartons
D-0371-2022	Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.; Lot # 100020800, exp 07/2022	11,450 vials

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product by checking the label for the specific name, lot number 100022393, and expiration date of 09/2022.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “Methylprednisolone, TN Norepinephrine BItartrate - MS, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Mississippi, Ohio, Tennessee.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Dec 31, 2021Firm started the recall
Jan 13, 2022FDA classified it Class II
Jan 19, 2022Published in FDA’s Enforcement Report
Jun 4, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The recall states there is a lack of assurance of sterility, so it may not be safe to use. The product should not be used until a replacement is obtained.

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Link to this recall

<a href="https://govinfonow.com/recall/35408-teva-methylprednisolone-acetate-injectable-suspension-recall-lack-of-sterility-assurance">Teva Methylprednisolone Acetate Injectable Suspension Recall: Lack of Sterility Assurance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0370-2022 (December 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0370-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.