CLASS II Drug recall · Reported 14 Jun 2023 · FDA Enforcement Report
Levsin injection (hyoscyamine sulfate injection, USP) recalled
Viatris is recalling Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for. The recall was initiated on 25 May 2023 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-0866-2023
- FDA event ID
- 92366
- Recalling firm
- Viatris, Canonsburg, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 May 2023
- FDA classified
- 5 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 25 May 2023 | Recall initiated by company | |
| 5 Jun 2023 | Classified by FDA | +11 days |
| 14 Jun 2023 | 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
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.
Product as listed by the FDA
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
Where it was distributed
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 101241A, Exp 10/23
Where was it sold?
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
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.
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