Labeling & mix-up recalls

2062 matching FDA recall record(s) · checked Aug 25, 2026

What this means

Labeling and mix-up recalls cover the wrong drug or strength in the package, incorrect labels, and cross-contamination between products. They matter because a patient can end up taking the wrong medicine or dose.

Recalls with this cause

Class III2026-07-29LIDOLOG KITLabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scanRecalling firm: Asclemed USA Inc.Read what it means & check your lot →Class I2026-07-29CETIRIZINE HYDROCHLORIDECross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined toRecalling firm: JB Chemicals and Pharmaceuticals LtdRead what it means & check your lot →Class II2026-07-08DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATELabeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.Recalling firm: Lannett Company Inc.Read what it means & check your lot →Class II2026-07-01PERAMPANELLabeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class III2026-06-24FOCALINLabeling: Incorrect or Missing Lot and/or Exp DateRecalling firm: Sandoz IncRead what it means & check your lot →Class III2026-06-17PRIMIDONECross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.Recalling firm: Amneal Pharmaceuticals, LLCRead what it means & check your lot →Class III2026-06-10LIDOLOG KITLabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scanRecalling firm: Eugia US LLCRead what it means & check your lot →Class II2026-06-10Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, FortLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name XyvonaRecalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2026-06-10Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, FortLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name XyvonaRecalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2026-05-27ATOMOXETINELabeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.Recalling firm: Safecor Health, LLCRead what it means & check your lot →Class III2026-05-27PRIMIDONECross contamination with other products: API contaminated with trace amounts of Acemetacin API.Recalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class III2026-05-27PRIMIDONECross contamination with other products: API contaminated with trace amounts of Acemetacin API.Recalling firm: Golden State Medical Supply Inc.Read what it means & check your lot →Class III2026-05-27PRIMIDONECross contamination with other products: API contaminated with trace amounts of Acemetacin API.Recalling firm: Golden State Medical Supply Inc.Read what it means & check your lot →Class III2026-05-27PRIMIDONECross contamination with other products: API contaminated with trace amounts of Acemetacin API.Recalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class III2026-05-27PRIMIDONECross contamination with other products: API contaminated with trace amounts of Acemetacin API.Recalling firm: Lannett Company Inc.Read what it means & check your lot →Class II2026-05-27Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: HaleLabeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.Recalling firm: Haleon US Holdings LLCRead what it means & check your lot →Class III2026-05-06LEVOCARNITINELabeling: Missing LabelRecalling firm: American Regent, Inc.Read what it means & check your lot →Class III2026-04-29MONSELS SOLUTIONLabeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to nRecalling firm: Premier Dental Products CoRead what it means & check your lot →Class III2026-03-04EPTIFIBATIDELabeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/10Recalling firm: Slate Run PharmaceuticalsRead what it means & check your lot →Class III2026-02-18DOXAZOSIN MESYLATETablets/Capsules Imprinted with Wrong IDRecalling firm: Unichem Pharmaceuticals USA Inc.Read what it means & check your lot →Class III2026-02-04PARODONTAXLabeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.Recalling firm: Haleon US Holdings LLCRead what it means & check your lot →Class II2026-02-04METHYLPREDNISOLONELabeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the direRecalling firm: Greenstone LlcRead what it means & check your lot →Class III2025-12-17NEBIVOLOLCross Contamination with Other ProductsRecalling firm: Glenmark Pharmaceuticals Inc., USARead what it means & check your lot →Class III2025-12-10BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDECross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibeRecalling firm: Glenmark Pharmaceuticals Inc., USARead what it means & check your lot →Class II2025-12-10HALOPERIDOL LACTATELabeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.Recalling firm: Safecor Health, LLCRead what it means & check your lot →Class I2025-11-26POTASSIUM CHLORIDELabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEqRecalling firm: Otsuka ICU Medical LLCRead what it means & check your lot →Class I2025-11-26POTASSIUM CHLORIDELabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEqRecalling firm: Otsuka ICU Medical LLCRead what it means & check your lot →Class II2025-11-12AEROTAB PAIN RELIEVERLabeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly Recalling firm: Aero HealthcareRead what it means & check your lot →Class III2025-11-05Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604Labeling: Not Elsewhere ClassifiedRecalling firm: Letco Medical LLCRead what it means & check your lot →Class III2025-10-29CETIRIZINE HYDROCHLORIDETablet/Capsules Imprinted with Wrong IDRecalling firm: JB Chemicals and Pharmaceuticals LtdRead what it means & check your lot →Class III2025-10-29CETIRIZINE HYDROCHLORIDETablet/Capsules Imprinted with Wrong IDRecalling firm: JB Chemicals and Pharmaceuticals LtdRead what it means & check your lot →Class II2025-10-29ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRYLabeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.Recalling firm: Church & Dwight Co., Inc.Read what it means & check your lot →Class III2025-10-22Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 Labeling: Incorrect or Missing Lot and/or Exp DateRecalling firm: STAQ Pharma, Inc.Read what it means & check your lot →Class III2025-10-22Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV Labeling: Incorrect or Missing Lot and/or Exp DateRecalling firm: STAQ Pharma, Inc.Read what it means & check your lot →Class III2025-10-22FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IVLabeling: Incorrect or Missing Lot and/or Exp DateRecalling firm: STAQ Pharma, Inc.Read what it means & check your lot →Class III2025-10-0170% ISOPROPYL RUBBING ALCOHOLCross Contamination with Other Products.Recalling firm: Consumer Product Partners, LLCRead what it means & check your lot →Class III2025-10-0170% ISOPROPYL RUBBING ALCOHOLCross Contamination with Other Products.Recalling firm: Consumer Product Partners, LLCRead what it means & check your lot →Class I2025-09-24CYCLOBENZAPRINE HYDROCHLORIDELabeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blueRecalling firm: Unichem Pharmaceuticals USA Inc.Read what it means & check your lot →Class II2025-09-03LISDEXAMFETAMINE DIMESYLATELabeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.Recalling firm: Lannett Company Inc.Read what it means & check your lot →Class III2025-08-27Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) ActivLabeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer caRecalling firm: Haleon US Holdings LLCRead what it means & check your lot →Class II2025-08-06AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELabeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027Recalling firm: Lupin Pharmaceuticals Inc.Read what it means & check your lot →Class III2025-07-23Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, CompoLabeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.Recalling firm: Qualgen, LLCRead what it means & check your lot →Class I2025-07-09CEFAZOLINLabeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials Recalling firm: Sandoz IncRead what it means & check your lot →Class I2025-07-09PENICILLIN G POTASSIUMLabeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million UnitRecalling firm: Sandoz IncRead what it means & check your lot →Class II2025-05-07Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mLabeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of theRecalling firm: Nubratori, IncRead what it means & check your lot →Class I2025-04-23LEVETIRACETAMLABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly iRecalling firm: Dr. Reddy's Laboratories, Inc.Read what it means & check your lot →Class III2025-04-16GABAPENTINCross ContaminationRecalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class III2025-04-16GABAPENTINCross ContaminationRecalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2025-04-02HYDROGEN PEROXIDELabeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl AlcoholRecalling firm: Consumer Product Partners, LLCRead what it means & check your lot →Class I2025-03-19POTASSIUM CHLORIDELabeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEqRecalling firm: ICU Medical, Inc.Read what it means & check your lot →Class I2025-03-19POTASSIUM CHLORIDELabeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strengthRecalling firm: ICU Medical, Inc.Read what it means & check your lot →Class I2025-02-12Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)Recalling firm: ENDO USA, Inc.Read what it means & check your lot →Class III2025-02-05BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoateLabeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.Recalling firm: The W.S. Badger Company, Inc.Read what it means & check your lot →Class III2025-01-22Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, MLabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Recalling firm: Akron Pharma, Inc.Read what it means & check your lot →Class III2025-01-22Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, ManLabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Recalling firm: Akron Pharma, Inc.Read what it means & check your lot →Class III2025-01-22Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, ManLabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Recalling firm: Akron Pharma, Inc.Read what it means & check your lot →Class III2025-01-22Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Recalling firm: Akron Pharma, Inc.Read what it means & check your lot →Class III2025-01-22Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, ManuLabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Recalling firm: Akron Pharma, Inc.Read what it means & check your lot →Class III2025-01-22Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron PhaLabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Recalling firm: Akron Pharma, Inc.Read what it means & check your lot →Class III2025-01-22Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron PhLabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Recalling firm: Akron Pharma, Inc.Read what it means & check your lot →

By cause