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FDAFDA recall D-0768-2026 · Aug 19, 2026

Heritage Pharmaceuticals Inc: CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION recall

Recall found

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

Reason for recall

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification
Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status
Ongoing
Codes, lots and dates
Lot #: 2411550, Exp. 2026/NOV.
Distribution
Nationwide within the U.S
Recalling firm
Heritage Pharmaceuticals Inc, East Brunswick, NJ
Voluntary or mandated
Voluntary: Firm initiated
Recall started
2026-07-30

Source: openFDA enforcement record D-0768-2026 · search recall number D-0768-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.

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