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
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Lots / codes
- 61224070074
- Distribution
- Nationwide
- Quantity
- 66,000 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0604-2025
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Class II Ongoing
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Lots / codes
- 61224080041
- Distribution
- Nationwide
- Quantity
- 300000 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0603-2025
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Class II Ongoing
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Lots / codes
- 61224070073
- Distribution
- Nationwide
- Quantity
- 3,456,000 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0602-2025
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Class II Ongoing
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www…
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Product
- CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
- Lots / codes
- 61224050002
- Distribution
- Nationwide
- Quantity
- 1,639,996 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0601-2025
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Class II Ongoing
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC…
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Product
- Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
- Lots / codes
- 61224040057
- Distribution
- Nationwide
- Quantity
- 6669874 swabs
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0600-2025
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Class II Ongoing
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
Reason: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Lots, distribution and details
- Product
- Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
- Lots / codes
- Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
- Distribution
- Nationwide in the USA.
- Quantity
- 125,040 bottles
- Recall started
- May 23, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0458-2025
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Class II Ongoing
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use…
Reason: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Lots, distribution and details
- Product
- BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
- Lots / codes
- Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
- Distribution
- Nationwide in the U.S.
- Quantity
- 385,200 applicators
- Recall started
- May 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0441-2025
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Class II Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Reason: cGMP deviations and lack of assurance of sterility.
Lots, distribution and details
- Lots / codes
- Lot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.
- Distribution
- Nationwide in the USA
- Quantity
- 14,333 cases (24 cartons per case)
- Recall started
- April 23, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0408-2025
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Class II Ongoing
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109.
Reason: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Lots, distribution and details
- Lots / codes
- Lot 0643188, exp. date 10/22/2026
- Distribution
- VA
- Quantity
- 25,932 bottles
- Recall started
- March 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0302-2025
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Class II Ongoing
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.
- Lots / codes
- SKU: CUR090737RB, Lot: 61224050002
- Distribution
- Nationwide
- Quantity
- 1,639,996 pads
- Recall started
- February 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0289-2025
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Class II Ongoing
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
- Lots / codes
- SKU: MDS090670, Lot: 61224040057
- Distribution
- Nationwide
- Quantity
- 6,669,874 pads
- Recall started
- February 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0288-2025
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Class I Ongoing
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton,…
Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Lots, distribution and details
- Product
- BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
- Lots / codes
- Lot #: 3200240, Exp 6/30/2026
- Distribution
- Nationwide and Canada
- Quantity
- 205,440 applicators
- Recall started
- February 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0259-2025
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Class II Ongoing
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured f…
Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Lots, distribution and details
- Product
- ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.
- Lots / codes
- Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
- Distribution
- FL
- Quantity
- 37,500 Boxes
- Recall started
- February 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0247-2025
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Class III Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Reason: LABELING: LABEL MIX-UP
Lots, distribution and details
- Lots / codes
- Lot #: 0160, Exp. Date April 26 2026
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- December 18, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0176-2025
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Class II Ongoing
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Reason: CGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: 042224-L1, Exp. Date 04/22/2025
- Distribution
- Product was sent to one distributor in North Carolina.
- Quantity
- 120 bottles
- Recall started
- September 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0667-2024
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Class II Completed
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4×1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon…
Reason: CGMP Deviations: sterile water not used for production
Lots, distribution and details
- Product
- HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4×1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210
- Lots / codes
- Lot #: a) 41320, Exp. Date 7/27/2024; 41020, Exp. Date 8/9/2024; BC06614, Exp. Date 8/15/2024; BCT07768, Exp. Date 9/23/2024; BCT09410, Exp. Date 11/17/2024; CCT02139, Exp. Date 3/10/2025; CCT01561, Exp. Date 3/15/2025; CCT02953, Exp. Date 4/10/2025; CCT02346, Exp. Date 4/21/2025; CCT03654, Exp. Date 5/11/2025; CCT04010, Exp. Date 5/17/2025; CCT07274, Exp. Date 8/24/2025; CCT09516, Exp. Date 11/1/2025; CCT10500, Exp. Date 12/5/2025; DCT01157, Exp. Date 2/1/2026; DCT01586, Exp. Date 2/14/2026; DCT03947, Exp. Date 4/30/2026; DCT04406, Exp. Date 5/24/2026; CCT01651, Exp. Date 2/21/2025 b) CCT03654, Exp. Date 5/11/2025 c) BCT07768, Exp. Date 9/23/2024; BCT07975, Exp. Date 9/29/2024; BCT09410, Exp. Date 11/17/2024; BCT10246, Exp. Date 12/20/2024; CCT00705, Exp. Date 1/23/2025; CCT01952, Exp. Date 3/3/2025; CCT02139, Exp. Date 3/10/2025; CCT02689, Exp. Date 3/30/2025; CCT02346, Exp. Date 4/21/2025; CCT03654, Exp. Date 5/11/2025; CCT04010, Exp. Date 5/17/2025; CCT04630, Exp. Date 6/6/2025; CCT05946, Exp. Date 7/17/2025; CCT06785, Exp. Date 8/10/2025; CCT07274, Exp. Date 8/24/2025; CCT08515, Exp. Date 10/2/2025; CCT08936, Exp. Date 10/13/2025; CCT09516, Exp. Date 11/1/2025; CCT10888, Exp. Date 12/18/2025; DCT01157, Exp. Date 2/1/2026; DCT01586, Exp. Date 2/14/2026; DCT02902, Exp. Date 3/27/2026; DCT03947, Exp. Date 4/30/2026; CCT01952, Exp. Date 3/3/2025; d) BC06614, Exp. Date 8/15/2024; CCT00705, Exp. Date 1/23/2025; CCT06785, Exp. Date 8/10/2025; CCT10500, Exp. Date 12/5/2025; DCT01586, Exp. Date 2/14/2026
- Distribution
- Nationwide within the United States and Toronto, Canada (Rubbing alcohol)
- Quantity
- —
- Recall started
- August 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0640-2024
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Class II Completed
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN…
Reason: CGMP Deviations: sterile water not used for production
Lots, distribution and details
- Product
- Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
- Lots / codes
- Lot #: a) BC05977, Exp. Date 08/05/2024; B06664, Exp. Date 08/17/2024, B06664, Exp. Date 08/17/2024; b) B06664, Exp. Date 08/17/2024; BC06867, Exp. Date 10/03/2024; BC06867, Exp. Date 10/03/2024; BCT08309, Exp. Date 10/11/2024; BK06696, Exp. Date 08/17/2024; CCT01774, Exp. Date 02/24/2025; CCT03579, Exp. Date 05/01/2025; CKM06510, Exp. Date 08/02/2025; DCT04332, Exp. Date 05/17/2026
- Distribution
- Nationwide within the United States and Toronto, Canada (Rubbing alcohol)
- Quantity
- 604
- Recall started
- August 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0639-2024
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Class II Ongoing
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Reason: Superpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: 100042386, Exp. Date 06/2025
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 7,080 unit dose packets
- Recall started
- August 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0637-2024
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Class II Ongoing
Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798…
Reason: CGMP deviations
Lots, distribution and details
- Product
- Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004
- Lots / codes
- lot code expiration dates are not on products: a) 023170, b) 023170
- Distribution
- Nationwide USA and Ontario, Canada (2 retailers)
- Quantity
- 20 spray bottles
- Recall started
- June 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0578-2024
-
Class I Ongoing
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol
Lots, distribution and details
- Product
- Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
- Lots / codes
- Lot #: 25160, Exp 4/16/2024; 25344, Exp 5/20/2024, 25580, Exp 6/15/2024; 25828, Exp 7/28/2024; 26057, Exp 8/25/2024; 26195, Exp 9/18/2024; 26471, Exp 11/25/2024; 26754, Exp 1/20/2025; 26821, Exp 2/2/2025; 27005, Exp 3/11/2025; 27518, Exp 6/22/2025; 27927, Exp 8/26/2025; 28176, Exp 10/22/2025; 28392, Exp 12/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 5299 bottles
- Recall started
- March 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0460-2024
-
Class I Ongoing
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by…
Reason: Chemical Contamination: Product manufactured with ethanol API that contains methanol
Lots, distribution and details
- Product
- Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean.
- Lots / codes
- Lot, expiry: (a) 25253, Exp 5/1/2024; 25976, Exp 8/11/2024; 26150, Exp 9/11/2024; 26473, Exp 11/25/2024; 26553, Exp 12/11/2024; 27318, Exp 5/10/2025; 27481, Exp 6/15/2025; 27660, Exp 7/15/2025; 27839, Exp 8/5/2025; 28121, Exp 10/7/2025; 28152, Exp 10/18/2025; 28355, Exp 12/17/2025; 28761, Exp 2/22/2026; 29088, Exp 4/1/2026; 29510, Exp 5/11/2026; 29558, Exp 5/13/2026; 29728, Exp 6/3/2026; 30339, Exp 9/13/2026; 30563, Exp 10/27/2026. (b) 25253, Exp 5/1/2024; 25976, Exp 8/11/2024; 26150, Exp 9/11/2024; 26553, Exp 12/11/2024; 26696, Exp 1/8/2025; 27318, Exp 5/10/2025; 27481, Exp 6/15/2025; 27660, Exp 7/15/2025; 27839, Exp 8/5/2025; 28281, Exp 11/30/2025; 28355, Exp 12/17/2025; 28761, Exp 2/22/2026; 29088, Exp 4/1/2026; 29728, Exp 6/3/2026; 30086, Exp 7/26/2026; 30339, Exp 9/13/2026; 30563, Exp 10/27/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 9,625 bottles
- Recall started
- March 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0459-2024
-
Class I Ongoing
Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-225…
Reason: Non-Sterility
Lots, distribution and details
- Product
- Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 9,216 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0308-2024
-
Class I Ongoing
Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 10,944 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0297-2024
-
Class I Ongoing
CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706…
Reason: Non-Sterility
Lots, distribution and details
- Product
- CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 253,080 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0296-2024
-
Class I Ongoing
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 1,492,344 bottles
- Recall started
- November 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0293-2024
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.