Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
3,228 recalls
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Class III Ongoing
Total Parental Nutrition – Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., A…
Reason: Incorrect Product Formulation
Lots, distribution and details
- Product
- Total Parental Nutrition – Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418
- Lots / codes
- Lot #: 20-1535990-0-1 & 20-1535892-0-1, Exp. Date 16 July 2026
- Distribution
- GA only
- Quantity
- (2) patient-specific TPN prescriptions
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0740-2026
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Class II Ongoing
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Reason: shortfill; reports of empty capsules.
Lots, distribution and details
- Lots / codes
- Batch # DMC125018A, Exp Date: 07/2027.
- Distribution
- US Nationwide.
- Quantity
- 6,408 bottles distributed to market
- Recall started
- July 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0733-2026
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Class III Ongoing
Dabigatran Etexilate Capsules, 75 mg, 30-count (3×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 4…
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots, distribution and details
- Product
- Dabigatran Etexilate Capsules, 75 mg, 30-count (3×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
- Lots / codes
- Lot: 25141586, Exp. April 30, 2027.
- Distribution
- USA Nationwide
- Quantity
- 936 cartons x 12 x 3 x 10 (in blister pack)
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0739-2026
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Class III Ongoing
Dabigatran Etexilate Capsules, 75 mg, 60-count (6×10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46…
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots, distribution and details
- Product
- Dabigatran Etexilate Capsules, 75 mg, 60-count (6×10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
- Lots / codes
- Lot: 25141585, Exp. April 30, 2027.
- Distribution
- USA Nationwide
- Quantity
- 924 cartons x 12 x 6 x 10 (in blister pack)
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0738-2026
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Class III Ongoing
Dabigatran Etexilate Capsules, 150 mg, 60-count (6×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN…
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots, distribution and details
- Product
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
- Lots / codes
- Lot: 25141583, Exp. April 30, 2027.
- Distribution
- USA Nationwide
- Quantity
- 3,600 cartons x 6 x 10 (in blister pack)
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0737-2026
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Class II Ongoing
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & ND…
Reason: Presence of precipitate
Lots, distribution and details
- Product
- Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).
- Lots / codes
- Lot #: 3241653, Exp 4/30/2027
- Distribution
- USA Nationwide
- Quantity
- 5688 vials
- Recall started
- July 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0734-2026
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Class II Ongoing
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Reason: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Lots, distribution and details
- Lots / codes
- Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
- Distribution
- Nationwide within the United States.
- Quantity
- N/A
- Recall started
- July 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0731-2026
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Class II Ongoing
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL – bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.
Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Lots, distribution and details
- Lots / codes
- Lot # DLHU0031, Exp Date: 06/30/2027.
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 22, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0730-2026
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Class III Ongoing
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 U…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.
- Lots / codes
- Lot # 2075801, Exp Date: 31-Oct-2029.
- Distribution
- US Nationwide.
- Quantity
- 15,853 bottles
- Recall started
- July 6, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0758-2026
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Class II Ongoing
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot# 704C003, Exp. 12/31/2028
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- June 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0742-2026
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Class II Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot # 506033, Exp Date: 11/30/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0741-2026
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Class III Ongoing
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2×10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Lots, distribution and details
- Lots / codes
- Lot: 25141584, Exp 4/30/2027.
- Distribution
- USA Nationwide
- Quantity
- 2,717 cartons
- Recall started
- June 30, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0736-2026
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Class III Ongoing
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6×10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Lots, distribution and details
- Lots / codes
- Lot: 25141707, Exp 4/30/2027.
- Distribution
- USA Nationwide
- Quantity
- 1,753 cartons
- Recall started
- June 30, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0735-2026
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Class I Ongoing
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings…
Reason: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Lots, distribution and details
- Product
- Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
- Lots / codes
- Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
- Distribution
- Nationwide in the USA
- Quantity
- 34,020 100-count bottles.
- Recall started
- June 24, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0732-2026
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Class II Ongoing
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
Reason: Presence of Particulate Matter: Hair was found in products
Lots, distribution and details
- Product
- Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
- Lots / codes
- Lot #: 6133986, Exp. Date 02/2029
- Distribution
- Nationwide within in the USA
- Quantity
- 37,250 vials
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0729-2026
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Class II Ongoing
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Reason: Presence of Particulate Matter: Hair was found in products
Lots, distribution and details
- Product
- Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
- Lots / codes
- Lot #: 6130235, Exp. Date 02/2027
- Distribution
- Nationwide within in the USA
- Quantity
- 93,250 vials
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0728-2026
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Class II Ongoing
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-0…
Reason: Presence of Particulate Matter: Hair was found in products
Lots, distribution and details
- Product
- Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
- Lots / codes
- Lot #: 6133436, Exp. Date 10/2028
- Distribution
- Nationwide within in the USA
- Quantity
- 92,600 vials
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0727-2026
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Class II Ongoing
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
Reason: Presence of Particulate Matter: Hair was found in products
Lots, distribution and details
- Product
- Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
- Lots / codes
- Lot #: 6133801, Exp. Date 01/2028
- Distribution
- Nationwide within in the USA
- Quantity
- 181,225 vials
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0726-2026
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Class II Ongoing
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Reason: Presence of Particulate Matter: Hair was found in product
Lots, distribution and details
- Product
- Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
- Lots / codes
- Lot #: 6134349, 6134620 Exp. Date 11/2026
- Distribution
- Nationwide within in the USA
- Quantity
- 59,425 vials
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0725-2026
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Class II Ongoing
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-…
Reason: Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Lots, distribution and details
- Product
- Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.
- Lots / codes
- Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.
- Distribution
- Nationwide U.S.A.
- Quantity
- 74208 units
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0724-2026
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Class II Ongoing
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 31074201…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
- Lots / codes
- Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.
- Distribution
- Nationwide within the United States
- Quantity
- 2910148 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0722-2026
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Class II Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
- Lots / codes
- Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08
- Distribution
- Nationwide within the United States
- Quantity
- 353 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0721-2026
-
Class II Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11.
- Distribution
- Nationwide within the United States
- Quantity
- 97201 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0720-2026
-
Class II Ongoing
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
- Lots / codes
- Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
- Distribution
- Nationwide within the United States
- Quantity
- 65219 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0719-2026
-
Class II Ongoing
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UP…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
- Lots / codes
- Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.
- Distribution
- Nationwide within the United States
- Quantity
- 1,278,457 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0718-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.