Antibiotics recalls

The FDA has published 492 recalls involving antibiotics since 2012. The latest was reported on 9 Sep 2026. Most were for sterility. Lupin Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls492since 2012
Last 12 months16reported
Class I306% of total
Ongoing74latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 30 6%Class II 407 83%Class III 55 11%

By year

Ongoing antibiotics recalls

74 active

All antibiotics recalls, newest first

492 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIClindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIVancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin HydrochlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIClindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIVancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin HydrochlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIClindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIClindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIClindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIClindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate HydrochlorideHeritage PharmaceuticalsParticulate MatterNationwide
DrugCLASS IIVancomycin HCL added to, 0.9% Sodium Chloride Injection recalledFagron Compounding ServicesSterilityNationwide
DrugCLASS IIVancomycin HCI added to, 0.9% Sodium Chloride Injection recalledFagron Compounding ServicesSterilityNationwide
DrugCLASS IIVancomycin HCI added to, 0.9% Sodium Chloride Injection recalledFagron Compounding ServicesSterilityNationwide
DrugCLASS IIvancomycin HCl added to, 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIvancomycin HCl added to, 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIIClindamycin Phosphate USP, 1% (10 mg/mL) recalledClindamycin PhosphateSUN Pharmaceutical IndustriesPotency & AssayNationwide
DrugCLASS IIAmoxicillin and Clavulanate Potassium recalledTeva Pharmaceuticals USAPotency & AssayCA, MS, OH
DrugCLASS IIDoxycycline Hyclate Tablets, USP 100 mg* recalledDoxycyclineAcella PharmaceuticalsPotency & AssayNationwide
DrugCLASS IISulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And TrimethoprimNorthwind PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And TrimethoprimThe Harvard Drug GroupPackaging DefectsNationwide
DrugCLASS IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And TrimethoprimThe Harvard Drug GroupPackaging DefectsNationwide
DrugCLASS IICiprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And DexamethasoneSandozTemperature AbuseCA
DrugCLASS IISulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And TrimethoprimAmneal PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IIBicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-aPfizerParticulate MatterNationwide
DrugCLASS IIBicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-aPfizerParticulate MatterNationwide
DrugCLASS IBuffered Penicillin G Potassium for Injection recalled by SandozPenicillin G PotassiumSandozLabeling ErrorsNationwide
DrugCLASS IICephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalledCephalexinAscend LaboratoriesPotency & AssayNationwide
DrugCLASS ISulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And TrimethoprimAmneal PharmaceuticalsSterilityNationwide
DrugCLASS IICephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalledCephalexinAscend LaboratoriesPotency & AssayNationwide
DrugCLASS IIClindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePackRemedyRePackManufacturing (CGMP) DeviationsFL, PA, VA
DrugCLASS IIClindamycin Hydrochloride Capsules, USP, 300mg recalledPreferred PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIClindamycin HCl, QTY recalled by RemedyRepackRemedyRepackManufacturing (CGMP) DeviationsPA

Should you stop taking Antibiotics?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.