July 2026 FDA Recall Clindamycin Palmitate Hydrochloride by Heritage Pharmaceuticals Inc
D-0768-2026 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Heritage Pharmaceuticals Inc on July 30, 2026 for the product Clindamycin Palmitate Hydrochloride. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0768-2026
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
07-30-2026
08-19-2026
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Heritage Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the U.S
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
