thejoe Triamcinolone Acetonide

Triamcinolone Acetonide recalls: 5 FDA reports

Recalls involving Triamcinolone Acetonide. What was wrong with each batch, and how the FDA graded the risk.

5Reports

0Class I

1Ongoing

2023-10-11Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	4
Class III	1

By year reported

Year	Reports
2014	1
2021	1
2022	2
2023	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx O

D-0041-2024 · Class II · reported 2023-10-11 · Ongoing

Why it was recalled: Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Product: Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.
Where it went: Nationwide in the USA
How much: 1,626 vials

Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distrib

D-1497-2022 · Class II · reported 2022-09-07 · Terminated

Why it was recalled: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Product: Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Where it went: Nationwide in the USA
How much: 57,816 tubes

Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15

D-1106-2022 · Class II · reported 2022-06-15 · Terminated

Why it was recalled: cGMP deviations: Temperature abuse
Product: Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15
Where it went: USA nationwide.
How much: 30 tubes

Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 458

D-0551-2021 · Class II · reported 2021-06-02 · Terminated

Why it was recalled: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product: Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36
Where it went: FL, GA, SC
How much: 178 tubes

Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fo

D-1152-2014 · Class III · reported 2014-03-19 · Terminated

Why it was recalled: Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Product: Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Where it went: Nationwide.
How much: 493,192 tubes

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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