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.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reason: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Lots, distribution and details
- Lots / codes
- Lot #: AC-016581
- Distribution
- MO
- Quantity
- 215 bags
- Recall started
- February 8, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0487-2023
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Class I Ongoing
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Lots, distribution and details
- Lots / codes
- Batch # H29, Exp. Date 11/30/2023
- Distribution
- Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
- Quantity
- 50,000 tubes
- Recall started
- February 24, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0488-2023
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Class II Ongoing
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3
Reason: Defective Delivery System: Out of specification for shear.
Lots, distribution and details
- Lots / codes
- Lot#: 91474, 91959, Exp. 3/2023; 91958, Exp. 6/2023; 92478, Exp. 7/2023; 92479 & 92198, Exp. 8/2023; 92199, 93040, Exp. 9/2023; 93041, Exp. 10/2023.
- Distribution
- US Nationwide
- Quantity
- N/A
- Recall started
- March 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0473-2023
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Class II Ongoing
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.
Reason: Defective Delivery System: Out of specification for shear.
Lots, distribution and details
- Product
- Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.
- Lots / codes
- Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
- Distribution
- US Nationwide
- Quantity
- N/A
- Recall started
- March 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0472-2023
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Class II Ongoing
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3
Reason: Defective Delivery System: Out of specification for shear.
Lots, distribution and details
- Lots / codes
- Lot#: 91956, Exp. 6/2023; 92475, Exp. 7/2023
- Distribution
- US Nationwide
- Quantity
- N/A
- Recall started
- March 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0471-2023
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Class II Ongoing
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.
Reason: Defective Delivery System: Out of specification for shear.
Lots, distribution and details
- Lots / codes
- Lot#: 91955, Exp. 7/2023; 93039, Exp. 10/2023
- Distribution
- US Nationwide
- Quantity
- N/A
- Recall started
- March 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0470-2023
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Class III Ongoing
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan,…
Reason: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Lots, distribution and details
- Product
- Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
- Lots / codes
- Lot# SCDR, Exp 02/2024
- Distribution
- Nationwide in the USA
- Quantity
- 43,238 cartons
- Recall started
- February 21, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0464-2023
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Class II Ongoing
Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 1808051, Exp.: 01/01/2027
- Distribution
- Nationwide in the USA and Worldwide through e-commerce and trade shows
- Quantity
- 995 bottles
- Recall started
- February 14, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0457-2023
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Class I Ongoing
Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- Lot #s: a) 1808051, Exp.: 01/01/2027; b) 2203PS01, Exp.: 01/01/2027
- Distribution
- Nationwide in the USA and Worldwide through e-commerce and trade shows
- Quantity
- a) 869 bottles; b) 1035 bottles
- Recall started
- February 14, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0456-2023
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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
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Lots, distribution and details
- Product
- NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
- Lots / codes
- Lot: 222016, Exp: 01/25;
- Distribution
- Nationwide in the USA.
- Quantity
- 4004
- 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-0438-2023
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Class II Ongoing
NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Lots, distribution and details
- Product
- NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
- Lots / codes
- Lot: 221263, Exp: 10/24; 222047, 222048 Exp: 02/25; 222099, 222100, Exp: 03/25
- Distribution
- Nationwide in the USA.
- Quantity
- 13,974
- 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-0437-2023
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Class II Ongoing
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally – 500 090, INDIA; NDC 55111-525-01.
Reason: Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Lots, distribution and details
- Lots / codes
- Lot # C2106445; Exp. 03/2024
- Distribution
- Nationwide in the USA
- Quantity
- 4,320 bottles
- Recall started
- February 8, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0330-2023
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Class II Ongoing
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
Reason: CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Lots, distribution and details
- Lots / codes
- Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
- Distribution
- Nationwide in the USA
- Quantity
- 3186 bottles
- Recall started
- January 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0326-2023
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Class II Ongoing
Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
Reason: CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Lots, distribution and details
- Product
- Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
- Lots / codes
- Lots 3217A and 3217B, exp 06/23
- Distribution
- Nationwide in the USA
- Quantity
- 4 oz: 6580 bottles; 8 oz: 1248 bottles
- Recall started
- January 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0325-2023
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Class III Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Reason: Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Lots, distribution and details
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
- Lots / codes
- Lot: 081031A, Exp 2/28/2023
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 45,117 Bottles
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0265-2023
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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
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Class II Ongoing
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
- Lots / codes
- Lot: 1D94A, EXP 3/31/2023; 1E35A, EXP 4/30/2023; 2A06A, EXP 12/31/2023
- Distribution
- Nationwide in the USA
- Quantity
- 91,692 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-0158-2023
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Class II Ongoing
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
- Lots / codes
- Lot: 1C56A, EXP 2/28/2023; 1J50A, EXP 8/31/2023; 1K61A, EXP 9/30/2023 ; 1M27A, EXP 11/30/2023;
- Distribution
- Nationwide in the USA
- Quantity
- 2,095,068 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-0157-2023
-
Class II Ongoing
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactu…
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
- Lots / codes
- Lot: (a) 0B50A, 0B69A, EXP 1/31/2023; 0C74A, EXP 2/28/2023; 0D04A, EXP 3/31/2023; 0E37A, EXP 4/30/2023; 0G07A, 0G82A, EXP 6/30/2023; 0H26A, 0H28A, 0H53A, 0H36A, EXP 7/31/2023; 0J64A, 0J58A, 0J66A, EXP 8/31/2023; 0K96A, 0K06A, 0K98A, 0K04A, 0K03A, 0K99A, EXP 9/30/2023; 0L72A, EXP 10/31/2023; 0M81A, 0M85A, 0M80A, 0M84A, 0M82A, 0M83A, EXP 11/30/2023; 1A01A, 1A02A, EXP 12/31/2023; 1B16A, 1B13A, 1B17A, EXP 1/31/2024; 1C51A, EXP 2/29/2024; (b) 0B59A , EXP 1/31/2023;0E49A, EXP 4/30/2023; 0G14A, EXP 6/30/2023; 0H38A, EXP 7/31/2023; 0J84A, EXP 8/31/2023; 0K05A, EXP 9/30/2023; 0L59A, EXP 10/31/2023; 0M86A, 0M87A, EXP 11/30/2023; 1A03A, EXP 12/31/2023; 1B37A, EXP 1/31/2024; 1C63A, EXP 2/29/2024; 1C54A, EXP 2/29/2024; 1D83A, EXP 3/31/2024; (c) 0C82A, EXP 2/28/2023; 0G84A, EXP 6/30/2023; 0H49A, EXP 7/31/2023; 0J77A, EXP 8/31/2023; 0J75A, EXP 8/31/2023; 0L57A, EXP 10/31/2023; 0L74A, EXP 10/31/2023; 0L46A, EXP 10/31/2023; 1G52A, EXP 6/30/2024; 1J52A, EXP 8/31/2024;
- Distribution
- Nationwide in the USA
- Quantity
- 1,310,324 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-0156-2023
-
Class II Ongoing
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
- Lots / codes
- Lot: 0F69A, EXP 5/31/2023; 0G92B, 0G92A, EXP 6/30/2023; 0J69A, EXP 8/31/2023; 0K29A, 0K24A, EXP 9/30/2023; 0M93A, 0M92A, 0M92B, EXP 11/30/2023; 1B25A, EXP 1/31/2024; 1C74A, EXP 2/29/2024; 1E19A, EXP 4/30/2024; 1C77A, EXP 2/29/2024;
- Distribution
- Nationwide in the USA
- Quantity
- 524,506 tubes
- 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-0155-2023
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 November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.