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.
1,094 recalls
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Class II Terminated
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Reason: Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Lots, distribution and details
- Lots / codes
- Lot # C2305569, Exp. date 03/31/2026
- Distribution
- Nationwide
- Quantity
- 1,656 bottles
- Recall started
- October 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0086-2024
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Class II Terminated
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-39…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88
- Lots / codes
- Lot #: DNC2204A, Exp. Date 11/2023
- Distribution
- Nationwide within the United States
- Quantity
- 2304 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-0084-2024
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Class II Terminated
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88
- Lots / codes
- Lot #: DND0058A, Exp. Date 12/2023
- Distribution
- Nationwide within the United States
- Quantity
- 7392 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-0083-2024
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Class II Ongoing
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis,…
Reason: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Lots, distribution and details
- Product
- Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01
- Lots / codes
- Lot#: 164185, Exp. Date 4/2024
- Distribution
- Nationwide within the United States
- Quantity
- 10,512 cartons
- Recall started
- September 28, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0081-2024
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Class III Ongoing
Methotrexate Tablets, USP, 2.5 mg, 10×10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
Reason: Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Lots, distribution and details
- Product
- Methotrexate Tablets, USP, 2.5 mg, 10×10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
- Lots / codes
- Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024
- Distribution
- MS, OH
- Quantity
- 2,673 cartons
- Recall started
- September 22, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0066-2024
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Class II Ongoing
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Reason: CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Lots, distribution and details
- Lots / codes
- Certain drug products sold by Family Dollar retail stores located in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.
- Distribution
- Nationwide in the USA
- Quantity
- 4,261,383 units of various products
- Recall started
- October 5, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0045-2024
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Class I Ongoing
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- Lot: 6786, Exp: 03/31/25
- Distribution
- Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.
- Quantity
- N/A
- Recall started
- August 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0037-2024
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Class II Ongoing
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot: 6485, Exp: 11/23: 6562, Exp: 03/24; 6624, Exp: 06/24; 6669, Exp: 08/24; 6688, Exp: 09/24; 6727, EXP: 11/24; 6771, Exp: 02/25; 6830, Exp: 03/25; 6887, Exp: 07/25.
- Distribution
- Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.
- Quantity
- 3833 bottles
- Recall started
- August 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0036-2024
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Class II Ongoing
Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot: 6666, Exp. 11/30/25
- Distribution
- Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.
- Quantity
- 1744 bottles
- Recall started
- August 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0035-2024
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Class II Ongoing
Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot: 6617, Exp. 05/24; 6623, Exp 06/24; 6646, Exp 07/24; 6675, Exp 09/24; 6716, Exp 11/24.
- Distribution
- Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.
- Quantity
- 795 bottles
- Recall started
- August 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0034-2024
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Class II Ongoing
Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001036
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lots: 6486, Exp: 11/23; 6536, Exp: 01/24; 6549, Exp: 02/24; 6561, Exp: 03/24; 6623, Exp: 06/24; 6630, Exp: 06/24; 6646, Exp: 07/24; 6675, Exp: 09/24; 6686, Exp: 09/24; 6695, Exp: 10/24; 6738, Exp: 11/24; 6767, Exp: 01/25; 6787, Exp: 03/25; 6799, Exp: 04/25; 6832 Exp: 05/25; 6844, Exp: 05/25; 6857, Exp: 06/25; 6888, Exp: 07/25.
- Distribution
- Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.
- Quantity
- 6060 bottles
- Recall started
- August 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0033-2024
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Class I Ongoing
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover…
Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Lots, distribution and details
- Product
- SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
- Lots / codes
- FX001691, Exp. 12/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1272 bottles
- Recall started
- September 8, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-1174-2023
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Class II Ongoing
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 282,564 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1160-2023
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Class II Ongoing
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
Lots, distribution and details
- Lots / codes
- Miscellaneous
- Distribution
- Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
- Quantity
- Unknown
- Recall started
- August 14, 2023 (N/A)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1104-2023
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Class II Ongoing
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
- Lots / codes
- Lot 22122841, Exp August 2025
- Distribution
- Nationwide in the USA
- Quantity
- 2652 bottles
- Recall started
- July 11, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0925-2023
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Class II Ongoing
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Lots, distribution and details
- Lots / codes
- Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0922-2023
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Class I Ongoing
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Lots, distribution and details
- Lots / codes
- Lot #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0921-2023
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Class II Ongoing
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Lots, distribution and details
- Lots / codes
- Lot #: PCMH009, PCMH010, PCMH011, PCMH012, PCMH013, PCMH014, PCMH015, PCMH016, exp. date Nov-2023; PCMI001, PCMI002, PCMI003, PCMI004, PCMI006, PCMI 07, PCMI 008, Exp. date AUG-2024; PCMJ003, PCMJ007, PCMJ016, Exp. date MAR-2025
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0920-2023
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Class I Ongoing
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Lots, distribution and details
- Lots / codes
- Lot #: PCMI005, Exp. date AUG-2024; PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, PCMJ015, Exp. date MAR-2025
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Quantity
- 400,008 bottles total for all products
- Recall started
- January 30, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0919-2023
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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
Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL…
Reason: CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Lots, distribution and details
- Product
- Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05
- Lots / codes
- Lot #: a) LT21FO2, LT21F03, Exp 6/2023; b) LT21FO2, LT21F03, Exp 6/2023; c) LT21FO2, LT21F03, Exp 6/2023; d) LT21FO2, LT21F03, Exp 6/2023; e) LT21F02, Exp 6/2023; f) LT21F02, Exp 6/2023; g) LT21F03, Exp 6/2023; h) LT21F03, Exp 6/2023; i) LT21F03, Exp 6/2023
- Distribution
- Nationwide in the USA
- Quantity
- 397,430 bottles
- Recall started
- June 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0898-2023
-
Class II Ongoing
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072…
Reason: CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Lots, distribution and details
- Product
- Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; g) Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3; h) Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3
- Lots / codes
- Lot #: a) RG21F01, Exp: 6/30/2023; b) RG21F01, Exp: 6/30/2023; c) RG21F01, Exp: 6/30/2023; d) RG21F01, RG21F02, Exp 6/30/2023; e) RG21F02, RG21F03, Exp 6/30/2023; f) RG21F02, Exp 6/30/2023; g) RG21F02, Exp 6/30/2023; h) RG21F02, Exp 6/30/2023; i) RG21F02, Exp 6/30/2023; j) RG21F02, Exp 6/30/2023; k) RG21F02, Exp 6/30/2023; l) RG21F02, Exp 6/30/2023; m) RG21F03, Exp 6/30/2023; n) RG21F03, Exp 6/30/2023; o) RG21F03, Exp 6/30/2023; p) RG21F03, Exp 6/30/2023
- Distribution
- Nationwide in the USA
- Quantity
- 341,568 bottles
- Recall started
- June 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0897-2023
-
Class II Ongoing
Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx 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
- 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-0864-2023
-
Class II Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, 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
- 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-0862-2023
-
Class II Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, 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
- 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-0861-2023
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 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.