Drug recall: Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak…

Class II FDA enforcement event 93345. Recall start date: 1 Nov 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Class II, in the words of FDA

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

Padagis US LLC started this drug recall on 1 Nov 2023. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class II. FDA event 93345 has 1 product record. The first FDA enforcement report date is 13 Dec 2023. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA

Recalling firm

Padagis US LLC, Minneapolis, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 93345: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0139-2024	Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30	7,032 bottles	Class II	Ongoing	13 Dec 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2023: 281
Share of these events in Class II: 59%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Padagis US LLC
Initiated	Product (first record)	Type	Class	Records
23 Jun 2026	Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Isr	Drug	Class II	1
6 Feb 2025	Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham,	Drug	Class II	1
11 Oct 2024	Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427	Drug	Class III	1
28 Sep 2023	Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefille	Drug	Class II	1
21 Feb 2023	Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Onl	Drug	Class III	1
17 Aug 2022	Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Pe	Drug	Class II	1
27 Dec 2021	Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeru	Drug	Class II	1

Padagis US LLC: all 8 events

Official channels

FDA enforcement report D-0139-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 93345. https://recallregister.com/fda/ii/93345/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA
What quantity of product is in FDA event 93345?: The FDA record gives this quantity: 7,032 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2023 have the same class?: 59% of the 281 drug events that started in 2023 are in Class II.