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.
1,070 recalls
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml – 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Lots / codes
- Lots: G23W03B, Exp. 8/4/2027; A16X02, Exp. 1/20/2029: A16X03, Exp. 1/22/2029.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 2,149 90mL-Tubes
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0826-2026
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml – 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 0747…
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml – 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
- Lots / codes
- Lots: H22V02A, Exp. 8/30/2026; C13W01B, Exp. 3/27/2027; C24W01, Exp. 4/28/2027; G23W02, Exp. 7/25/2027; G23W01B, Exp. 7/24/2027; K10W02, Exp. 10/21/2028.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 23,941, 20mL-Tube
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0825-2026
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml – 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.…
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml – 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
- Lots / codes
- Lots: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 27,492 3mL Sachets
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0824-2026
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML – 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Lots / codes
- Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 29,014 50mL Tubes
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0823-2026
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Class III Ongoing
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot # DMA25006, Exp Date: 11/30/2028.
- Distribution
- US Nationwide.
- Quantity
- 14,232 bottles (1,423,200 tablets)
- Recall started
- August 7, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0822-2026
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Class II Ongoing
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
Reason: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Lots, distribution and details
- Lots / codes
- Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.
- Distribution
- US Nationwide.
- Quantity
- 318,600 cartons
- Recall started
- August 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0790-2026
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Class II Ongoing
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51…
Reason: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Lots, distribution and details
- Product
- Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
- Lots / codes
- Lot # AD94033, Exp Date: 5/31/2028.
- Distribution
- US Nationwide.
- Quantity
- 1968 Bottles (1000Tablets/Bottle)
- Recall started
- August 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0770-2026
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Class II Ongoing
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC:…
Reason: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Lots, distribution and details
- Product
- PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
- Lots / codes
- Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
- Distribution
- Nationwide in the USA.
- Quantity
- 9,489 50mL vials
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0765-2026
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Class II Ongoing
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC…
Reason: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Lots, distribution and details
- Product
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
- Lots / codes
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Distribution
- Nationwide in the USA.
- Quantity
- 18,434 10mL vials
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0764-2026
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Class II Ongoing
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Reason: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Lots, distribution and details
- Lots / codes
- Lot #: 2411550, Exp. 2026/NOV.
- Distribution
- Nationwide within the U.S
- Quantity
- —
- Recall started
- July 30, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0768-2026
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Class II Ongoing
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot AV5913C, Expiry: 6/2027
- Distribution
- US Nationwide
- Quantity
- —
- Recall started
- August 4, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0746-2026
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Class II Ongoing
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-…
Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Lots, distribution and details
- Product
- Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
- Lots / codes
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- August 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0745-2026
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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
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
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 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
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
-
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
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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.