Clindamycin Palmitate Hydrochloride Granule, For Solution
FDA Recall NDC 23155-603
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Clindamycin Palmitate Hydrochloride (NDC 23155-603). A significant event, classified as Class II, was initiated on Jul 30, 2026 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Jul 30, 2026
Aug 19, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99526
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Batch or Lot Expiration Information
Lot# : 2411550, Exp. 2026/NOV.
Affected Packages Involved in this Recall
23155-603-51Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
