FDA company announcement
Zendedi: dextroamphetamine sulfate tablets, 30 mg
Mislabeled package
Not suppliedReported terminated
Distribution: Not supplied
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Azurity Pharmaceuticals, Inc. recall records
0 reported ongoing
4 records in this archive. Latest source date Jan 25, 2024.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Records and reported status
Official source for Zendedi: dextroamphetamine sulfate tablets, 30 mg
FDA drug enforcement
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Labeling: Label Mix-up
Class IReported terminated
Distribution: USA nationwide
FDA drug enforcement
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class IIIReported terminated
Distribution: USA nationwide.
FDA drug enforcement
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, M...
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class IIReported terminated
Distribution: US Nationwide
Reasons in these listed records
- Mislabeled package
- Labeling: Label Mix-up
- Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
- cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
These examples come from this result page and are not a ranking of every recall reason.
Checking Azurity Pharmaceuticals, Inc.
Is there a recall on azurity pharmaceuticals, inc. right now?
This archive contains 4 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product?
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included?
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record?
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.