Viatris recalls Levsin injection (0.5 mg/ml) due to quality program discontinuation. This may affect product identity, strength, quality, and purity. Check NDC #0037-9001-05 and lot 101241A.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
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Contact the company
📍Recalling firmViatris Inc1000 Mylan Blvd · Canonsburg, PA 15317-5853
“Viatris Levsin Injection Recall: CGMP Deviations Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33428-viatris-levsin-injection-recall-cgmp-deviations-risk. Based on FDA recall #D-0866-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2023%22&limit=1).
The FDA announced on May 25, 2023, that Viatris Inc. is recalling Levsin injection (hyoscyamine sulfate injection, USP) due to CGMP deviations involving the discontinuation of its quality program. The recall affects 2,736 boxes distributed to ten distributors.
Strength/Volume: 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules)
NDC: #0037-9001-05
Lot #: 101241A
Expiration Date: 10/23
Quantity: 2,736 boxes
The hazard
The hazard stems from CGMP deviations caused by the discontinuation of the manufacturer's quality program. This action fails to assure that the product meets the identity, strength, quality, and purity characteristics purported or represented to possess.
Context
GovInfoNow's records show Viatris, Inc. has 10 other recalls on record since April 28, 2022. Other recent recalls of similar products include Viatris Xanax XR 3mg Tablets Recall (March 17, 2026), Viatris Cardura XL 8mg Tablets Recall (December 23, 2024), and Viatris Levothyroxine Tablets Recall (November 18, 2024). Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026), Baxter Vasopressin Injection Recall (August 6, 2026), and Wells Pharma Fentanyl Citrate Recall (April 1, 2026).
How to tell if you have this one
Check for the NDC code #0037-9001-05 and lot number 101241A on the product label. This product is only available by prescription and distributed by Viatris in the U.S.
Brand
Viatris
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC #0037-9001-05 and lot number 101241A on the label to confirm if the product is recalled.
How this recall unfolded
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0866-2023 (May 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0866-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.