Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Yes — there is an active recall. 13 ongoing FDA recalls mention Clindamycin (50 total). Check the affected lots below.
Most common reason: Sterility / contamination (16 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clindamycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
cGMP Deviations
CGMP Deviations
CGMP Deviations
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Defective Container: slow leakage under the cap
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Superpotent Drug
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of sterility assurance.
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
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