Labeling & mix-up recalls

2058 matching FDA recall record(s) · checked Jul 05, 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 IIIFOCALIN2026-06-24
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm: Sandoz Inc
Class IIIPRIMIDONE2026-06-17
Cross 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, LLC
Class IIILIDOLOG KIT2026-06-10
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Recalling firm: Eugia US LLC
Class IIXyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Fort2026-06-10
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Class IIXyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Fort2026-06-10
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Class IIATOMOXETINE2026-05-27
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Recalling firm: Safecor Health, LLC
Class IIIPRIMIDONE2026-05-27
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recalling firm: Amerisource Health Services LLC
Class IIIPRIMIDONE2026-05-27
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recalling firm: Golden State Medical Supply Inc.
Class IIIPRIMIDONE2026-05-27
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recalling firm: Golden State Medical Supply Inc.
Class IIIPRIMIDONE2026-05-27
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recalling firm: Amerisource Health Services LLC
Class IIIPRIMIDONE2026-05-27
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recalling firm: Lannett Company Inc.
Class IIGas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Hale2026-05-27
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Recalling firm: Haleon US Holdings LLC
Class IIILEVOCARNITINE2026-05-06
Labeling: Missing Label
Recalling firm: American Regent, Inc.
Class IIIMONSELS SOLUTION2026-04-29
Labeling: 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 n
Recalling firm: Premier Dental Products Co
Class IIIEPTIFIBATIDE2026-03-04
Labeling: 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/10
Recalling firm: Slate Run Pharmaceuticals
Class IIIDOXAZOSIN MESYLATE2026-02-18
Tablets/Capsules Imprinted with Wrong ID
Recalling firm: Unichem Pharmaceuticals USA Inc.
Class IIIPARODONTAX2026-02-04
Labeling: 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 LLC
Class IIMETHYLPREDNISOLONE2026-02-04
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the dire
Recalling firm: Greenstone Llc
Class IIINEBIVOLOL2025-12-17
Cross Contamination with Other Products
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIIBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2025-12-10
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIHALOPERIDOL LACTATE2025-12-10
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Recalling firm: Safecor Health, LLC
Class IPOTASSIUM CHLORIDE2025-11-26
Labeling: 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 mEq
Recalling firm: Otsuka ICU Medical LLC
Class IPOTASSIUM CHLORIDE2025-11-26
Labeling: 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 mEq
Recalling firm: Otsuka ICU Medical LLC
Class IIAEROTAB PAIN RELIEVER2025-11-12
Labeling: 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 Healthcare
Class IIIEspumil, Lipophilic foam base, 500 ml, 24G15-T02-1156042025-11-05
Labeling: Not Elsewhere Classified
Recalling firm: Letco Medical LLC
Class IIICETIRIZINE HYDROCHLORIDE2025-10-29
Tablet/Capsules Imprinted with Wrong ID
Recalling firm: JB Chemicals and Pharmaceuticals Ltd
Class IIICETIRIZINE HYDROCHLORIDE2025-10-29
Tablet/Capsules Imprinted with Wrong ID
Recalling firm: JB Chemicals and Pharmaceuticals Ltd
Class IIZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY2025-10-29
Labeling: 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.
Class IIIKetamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 2025-10-22
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm: STAQ Pharma, Inc.
Class IIIHydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV 2025-10-22
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm: STAQ Pharma, Inc.
Class IIIFentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV2025-10-22
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm: STAQ Pharma, Inc.
Class III70% ISOPROPYL RUBBING ALCOHOL2025-10-01
Cross Contamination with Other Products.
Recalling firm: Consumer Product Partners, LLC
Class III70% ISOPROPYL RUBBING ALCOHOL2025-10-01
Cross Contamination with Other Products.
Recalling firm: Consumer Product Partners, LLC
Class ICYCLOBENZAPRINE HYDROCHLORIDE2025-09-24
Labeling: 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 (blue
Recalling firm: Unichem Pharmaceuticals USA Inc.
Class IILISDEXAMFETAMINE DIMESYLATE2025-09-03
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Recalling firm: Lannett Company Inc.
Class IIISensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Activ2025-08-27
Labeling: 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 ca
Recalling firm: Haleon US Holdings LLC
Class IIAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE2025-08-06
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Recalling firm: Lupin Pharmaceuticals Inc.
Class IIITestosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compo2025-07-23
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Recalling firm: Qualgen, LLC
Class ICEFAZOLIN2025-07-09
Labeling: 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 Inc
Class IPENICILLIN G POTASSIUM2025-07-09
Labeling: 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
Recalling firm: Sandoz Inc
Class IIDexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 m2025-05-07
Labeling: 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 the
Recalling firm: Nubratori, Inc
Class ILEVETIRACETAM2025-04-23
LABELING: 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 i
Recalling firm: Dr. Reddy's Laboratories, Inc.
Class IIIGABAPENTIN2025-04-16
Cross Contamination
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Class IIIGABAPENTIN2025-04-16
Cross Contamination
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Class IIHYDROGEN PEROXIDE2025-04-02
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Recalling firm: Consumer Product Partners, LLC
Class IPOTASSIUM CHLORIDE2025-03-19
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Recalling firm: ICU Medical, Inc.
Class IPOTASSIUM CHLORIDE2025-03-19
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength
Recalling firm: ICU Medical, Inc.
Class IAdrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/302025-02-12
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Recalling firm: ENDO USA, Inc.
Class IIIBADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoate2025-02-05
Labeling: 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.
Class IIIAcetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, M2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class IIIDiphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Man2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class IIIDiphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Man2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class IIIAcetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron 2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class IIIDiphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manu2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class IIIAcetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pha2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class IIIAcetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Ph2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class ICLONAZEPAM2025-01-15
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Recalling firm: Endo USA, Inc.
Class ICLONAZEPAM2025-01-15
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Recalling firm: Endo USA, Inc.
Class ICLONAZEPAM2025-01-15
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Recalling firm: Endo USA, Inc.
Class ICLONAZEPAM2025-01-15
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Recalling firm: Endo USA, Inc.

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