CLASS I Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report

Senna Syrup (sennosides) 8.8 mg/ unit-dose cups recalled by Lohxa

Lohxa is recalling Senna Syrup (sennosides) 8.8 mg/ unit-dose cups, distributed nationwide in the US. The recall was initiated on 21 Dec 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: AM1115S, Exp. Date 01/2023
Quantity recalled87,840 unit dose cups

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-0377-2022
FDA event ID
89272
Recalling firm
Lohxa, Worcester, MA
Classification
Class I
Status
Terminated
Recall initiated
21 Dec 2021
FDA classified
18 Jan 2022
Reported
26 Jan 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

21 Dec 2021Recall initiated by company
18 Jan 2022Classified by FDA+28 days
26 Jan 2022Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Microbial Contamination of Non-Sterile Product

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.

Where it was distributed

Product was distributed to one wholesale who further distributed the product nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Microbial Contamination of Non-Sterile Product

Which lots are affected?

Lot #: AM1115S, Exp. Date 01/2023

Where was it sold?

Product was distributed to one wholesale who further distributed the product nationwide in the USA

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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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