Antibiotic recalls
59 FDA-recorded recalls of antibiotics, most recent Jun 2026 — newest first, straight from the FDA's own database.
Antibiotic recalls are usually manufacturing, sterility (for injectables) or potency failures on specific lots. A recalled antibiotic still needs to be replaced, not skipped — an incomplete course can leave an infection untreated — so check your lot against the FDA notice and contact your pharmacy for a replacement.
Minocycline Hydrochloride Extended-Release Tablets
Class IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Ascend Laboratories, LLC · Jun 17, 2026
Erythromycin Tablets
Class IICGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · May 27, 2026
Erythromycin Tablets
Class IICGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · May 27, 2026
Vancomycin HCI
Class IILack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services · Apr 15, 2026
Vancomycin HCI
Class IILack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services · Apr 15, 2026
Vancomycin HCL
Class IILack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services · Apr 15, 2026
vancomycin HCl
Class IILack of Assurance of Sterility
Fresenius Kabi Compounding, LLC · Feb 18, 2026
vancomycin HCl
Class IILack of Assurance of Sterility
Fresenius Kabi Compounding, LLC · Feb 18, 2026
Dexamethasone Moxifloxacin Ketorolac
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Jan 14, 2026
Dexamethasone Moxifloxacin
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Jan 14, 2026
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Jan 14, 2026
Clindamycin Phosphate USP
Class IIIFailed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 21, 2026
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Class IISubpotent drug; Clavulanate Potassium component
Teva Pharmaceuticals USA, Inc · Nov 12, 2025
Doxycycline Hyclate Tablets
Class IIFailed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Acella Pharmaceuticals, LLC · Oct 15, 2025
Sulfamethoxazole and Trimethoprim
Class IIPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 17, 2025
Sulfamethoxazole and Trimethoprim
Class IIPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 17, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class IIPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Northwind Pharmaceuticals LLC · Sep 24, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Sep 10, 2025
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Class IITemperature Abuse
Sandoz Inc · Sep 17, 2025
Bicillin L-A (penicillin G benzathine injectable suspension)
Class IICGMP Deviations; particulates identified during visual inspection
Pfizer Inc. · Aug 6, 2025
Buffered Penicillin G Potassium for Injection
Class ILabeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Sandoz Inc · Jul 9, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class IMicrobial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Amneal Pharmaceuticals, LLC · Jun 18, 2025
Cephalexin for Oral Suspension
Class IIFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Ascend Laboratories, LLC · Jun 18, 2025
Cephalexin for Oral Suspension
Class IIFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Ascend Laboratories, LLC · Jun 18, 2025
Clindamycin HCl Capsule
Class IICGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
RemedyRePack Inc. · May 14, 2025
Clindamycin Hydrochloride Capsules
Class IIcGMP Deviations
Preferred Pharmaceuticals, Inc. · May 7, 2025
Clindamycin HCl
Class IICGMP Deviations
RemedyRepack Inc. · Apr 30, 2025
Clindamycin Hydrochloride Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Ciprofloxacin Ophthalmic Solution USP
Class IIDefective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limited · Mar 26, 2025
CIPROFLOXACIN OPHTH SOLUTION
Class IIDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Direct Rx · Apr 23, 2025
Ciprofloxacin Ophthalmic Solution USP
Class IIDefective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limited · Jan 15, 2025
Nitrofurantoin Capsules
Class IIFailed Dissolution Specifications
AvKARE · Jan 8, 2025
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Oct 30, 2024
Ciprofloxacin ophthalmic solution USP
Class IIDefective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited · Aug 7, 2024
Nitrofurantoin Capsules
Class IIFailed Dissolution Specifications
SUN PHARMACEUTICAL INDUSTRIES INC · Jul 24, 2024
Amoxicillin and Clavulanate Potassium Tablets USP
Class IISubpotent Drug
Teva Pharmaceuticals USA, Inc · Jun 26, 2024
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocu…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · Jun 5, 2024
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · Jun 5, 2024
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · Jun 5, 2024
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocula…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · Jun 5, 2024
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · Jun 19, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Bryant Ranch Prepack, Inc. · Jun 12, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Bryant Ranch Prepack, Inc. · Jun 12, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Bryant Ranch Prepack, Inc. · Jun 12, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Bryant Ranch Prepack, Inc. · Jun 12, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Bryant Ranch Prepack, Inc. · Jun 12, 2024
Cefdinir for Oral Suspension USP
Class IIDefective container: lack of seal integrity.
Lupin Pharmaceuticals Inc. · Jun 5, 2024
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted)
Class IIPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc. · May 22, 2024
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted)
Class IIPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc. · May 22, 2024
minolira (minocycline hydrochloride) extended-release tablets
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · May 1, 2024
minolira (minocycline hydrochloride) extended-release tablets
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · May 1, 2024
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution…
Class IISubpotent Drug
Imprimis NJOF, LLC · May 8, 2024
Vancomycin Hydrochloride for Oral Solution
Class ISuperpotent Drug: Due to overfilling of drug powder
Amneal Pharmaceuticals of New York, LLC · Apr 24, 2024
Clindamycin Phosphate Topical Solution USP
Class IIIDefective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Contract Pharmaceuticals Limited Canada · Mar 13, 2024
Moxifloxacin 5mg/ml
Class IIPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Denver Solutions, LLC DBA Leiters Health · Mar 6, 2024
Moxifloxacin PF
Class IIPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Denver Solutions, LLC DBA Leiters Health · Mar 6, 2024
Clindamycin Phosphate
Class IIIDefective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Contract Pharmaceuticals Limited Canada · Mar 13, 2024
CABTREO (clindamycin phosphate
Class IICGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
MCKESSON CORPORATION · Feb 28, 2024
Bicillin L-A (Penicillin G Benzathine) 1.2
Class IIcGMP Deviations: Products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office · Mar 20, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Cholesterol medication · Diabetes medication · Antidepressant. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.