Clindamycin Palmitate Hydrochloride Recalled Due to the Presence of Foreign Substance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for clindamycin palmitate hydrochloride oral solution, 5 mg/5 mL. The affected batch has been identified as Lot 2411550 (expires November 2026).
• The recall was initiated by Heritage Pharmaceuticals, Inc due to the presence of a foreign substance, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Clindamycin is used to treat bacterial infections.

The FDA has issued a Class II recall for clindamycin palmitate hydrochloride oral solution, 5 mg/5 mL. This product is being recalled by Heritage Pharmaceuticals, Inc based in East Brunswick, New Jersey. The recall was initiated on July 30, 2026, and received a Class II classification on August 14, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the presence of foreign particles and white flakes in the product. This deficiency affects Lot 2411550, which will expire in November 2026. Heritage Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.

Clindamycin is used to treat bacterial infections. Pharmacists should identify and quarantine Lot 2411550, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 19, 2026. Accessed August 19, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221739