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.
128 recalls
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Class II Ongoing
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128…
Reason: CGMP Deviations: products may not conform to the labeled specifications.
Lots, distribution and details
- Product
- Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.
- Lots / codes
- Lot #: a) 2214500032, 2216700041, 2301900118, 2312600002, 2204800002, Exp. 02/05/2024; 2306100034, 2322000078, 2322200021 02/22/2024; 2318000026, Exp 02/24/2024; 2323000070, 2324400005, 2323300016, Exp 08/29/2025; 2324800079, Exp 08/30/2025; 2325800008, Exp 09/18/2025; 2328600011, 2328600032, 10/10/2025; 2324800123, Exp 10/11/2025; 2329700005, 2329700090, Exp 10/19/2025; 2330400003, Exp 10/25/2025; 2334100101, Exp 11/13/2025; 2335300019, 2335400038, Exp 12/19/2025. b) 2212200014, Exp 02/22/2024; 2323300017, Exp 08/29/2025; 2324800124, Exp 09/18/2025. c) 2211100001, Exp 02/24/2024; 2330500009, Exp 10/25/2025; 2333200014, Exp12/19/2025.
- Distribution
- Nationwide in the US
- Quantity
- 10,103 units
- Recall started
- January 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0287-2024
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Class II Ongoing
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
Reason: CGMP Deviations: products may not conform to the labeled specifications.
Lots, distribution and details
- Lots / codes
- Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
- Distribution
- Nationwide in the US
- Quantity
- 344 tubes
- Recall started
- January 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0286-2024
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Class II Terminated
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pra…
Reason: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Lots, distribution and details
- Product
- Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh – 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
- Lots / codes
- Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024
- Distribution
- USA Nationwide
- Quantity
- 38,496 bottles
- Recall started
- January 4, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0259-2024
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Class II Ongoing
Premier Value Tussin Cough DM, Dextromethorphan HBr…Cough Suppressant, Guaifenesin…Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA…
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Lots, distribution and details
- Product
- Premier Value Tussin Cough DM, Dextromethorphan HBr…Cough Suppressant, Guaifenesin…Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
- Lots / codes
- Lot # SD23033, Exp 04/30/2025
- Distribution
- MI, PA
- Quantity
- 4,176 bottles
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0215-2024
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Class III Terminated
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Reason: OOS for viscosity
Lots, distribution and details
- Lots / codes
- Lot #: 100029472, Exp. 2/29/2024
- Distribution
- USA nationwide
- Quantity
- —
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0127-2024
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Class I Ongoing
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in In…
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Product
- LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 11629 units
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0131-2024
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Class II Terminated
Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-0…
Reason: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Lots, distribution and details
- Product
- Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
- Lots / codes
- Lot #: 2134106, No Exp date, Manufacturing Date: 11/23/21
- Distribution
- Distributed to one distributor in OK with possibility of further distribution
- Quantity
- 1-55 gallon drum
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0111-2024
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Class II Terminated
Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
Reason: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Lots, distribution and details
- Product
- Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
- Lots / codes
- Lot #: 2133608, No exp Date. Manufacturing Date: 11/23/21
- Distribution
- Distributed to one distributor in OK with possibility of further distribution
- Quantity
- 1 55-gallon drum
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0110-2024
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Class II Terminated
Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03
Reason: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Lots, distribution and details
- Lots / codes
- Lot #: 2133607, Manufacturing Date 11/23/2021 No Exp date on label.
- Distribution
- Distributed to one distributor in OK with possibility of further distribution
- Quantity
- 1 55-gallon drum
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0109-2024
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Class I Terminated
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 1,271,810 bottles
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0107-2024
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Class II Ongoing
Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Lots, distribution and details
- Product
- Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
- Lots / codes
- Lot #s 006511
- Distribution
- Distributed in Puerto Rico only.
- Quantity
- 4,848 7.5 oz bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0105-2024
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Class II Ongoing
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Lots, distribution and details
- Lots / codes
- Lot #s 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, 0245096.
- Distribution
- Distributed in Puerto Rico only.
- Quantity
- 23,136 8 OZ bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0104-2024
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Class II Ongoing
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4
Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Lots, distribution and details
- Lots / codes
- Lot #s 1327034, 1328034, 1277029, 1278029, 1202015, 1203015, 0246097, 0247097, 0247099, 0248099, 0252099
- Distribution
- Distributed in Puerto Rico only.
- Quantity
- 48,145 4 oz bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0103-2024
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Class II Ongoing
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5;…
Reason: CGMP Deviation: impurities exceed allowable limits.
Lots, distribution and details
- Product
- Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL.
- Lots / codes
- All lots remaining within expiry.
- Distribution
- TN
- Quantity
- 540 gallons
- Recall started
- July 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0915-2023
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Class II Ongoing
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0808-2023
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Class II Ongoing
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Di…
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0807-2023
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Class II Ongoing
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0785-2023
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Class II Ongoing
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
Reason: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Lots, distribution and details
- Lots / codes
- Lot: 220888, Exp. 05/20/2023
- Distribution
- FL, GA, TX
- Quantity
- 2880 containers
- Recall started
- April 19, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0562-2023
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Class I Ongoing
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
Reason: Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA
- Quantity
- 500 bottles
- Recall started
- February 14, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0455-2023
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Class II Ongoing
NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0
Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Lots, distribution and details
- Product
- NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0
- Lots / codes
- Lot 222148, Exp: 05/25;
- Distribution
- Nationwide in the USA.
- Quantity
- 1590
- Recall started
- February 23, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0440-2023
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Class II Ongoing
NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA
Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Lots, distribution and details
- Lots / codes
- Lot 222076, Exp: 03/27;
- Distribution
- Nationwide in the USA.
- Quantity
- 8,146
- Recall started
- February 23, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0439-2023
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Class II Ongoing
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th St…
Reason: CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Lots, distribution and details
- Product
- SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522.
- Lots / codes
- Lots: 0001, 0005, 0007
- Distribution
- IA, NE
- Quantity
- a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles
- Recall started
- October 6, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0166-2023
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Class II Ongoing
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel – Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Reason: CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852
- Distribution
- Nationwide in the USA
- Quantity
- 106 bottles
- Recall started
- January 17, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0164-2023
-
Class II Ongoing
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel – Belgium, 1 Reagent Lane, Fair…
Reason: CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Lots, distribution and details
- Product
- Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel – Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
- Lots / codes
- Lot Numbers: 202160, 202162, 202324, 202368, 202369, 202593, 202594, 202835, 202862, 202863, 202865, 202836, 202864, 203061, 203098, 203099, 203100, 203101, 203102, 203236, 203237, 203239, 203337, 203338, 203335, 203336
- Distribution
- Nationwide in the USA
- Quantity
- a) 1077 bottles, b) 52 cases
- Recall started
- January 17, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0163-2023
-
Class II Ongoing
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
- Lots / codes
- Lot: 0L44A, 0L52A, 0L51A, 0L77A, 0L75A, EXP 10/31/2022; 0M02A, 0M01A, EXP 11/30/2022; 1C81A, EXP 2/28/2023; 1D02A, 1D03A, EXP 3/31/2023; 1E10A, 1E08A, 1E23A, 1E26A, 1E25A, 1E27A, 1E33A, EXP 4/30/2023; 1F46A, EXP 5/31/2023; 1G49A, 1G50A, 1G67A, EXP 6/30/2023; 1H04A, 1H74A,1H76A, 1H05A, 1H07A, 1H15A, 1H13A, 1H95A, EXP 7/31/2023; 1J44A, 1J20A, EXP 8/31/2023;
- Distribution
- Nationwide in the USA
- Quantity
- 967,075 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0134-2023
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.