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.
5 recalls
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Class II Ongoing
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc…
Reason: CGMP Deviations: use of an unapproved raw material
Lots, distribution and details
- Product
- Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
- Lots / codes
- Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
- Distribution
- Within U.S
- Quantity
- 113,943 Cartons
- Recall started
- March 19, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0474-2026
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Class II Ongoing
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc…
Reason: CGMP Deviations: use of an unapproved raw material
Lots, distribution and details
- Product
- Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch
- Lots / codes
- Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027
- Distribution
- Within U.S
- Quantity
- 62,136 Cartons
- Recall started
- March 19, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0473-2026
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Class II Ongoing
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc…
Reason: CGMP Deviations: use of an unapproved raw material
Lots, distribution and details
- Product
- Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch
- Lots / codes
- Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.
- Distribution
- Within U.S
- Quantity
- 124,054 Cartons
- Recall started
- March 19, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0472-2026
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Class II Ongoing
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuV…
Reason: Presence of Particulate Matter
Lots, distribution and details
- Product
- R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50
- Lots / codes
- Lot, expiry: 10149179 , exp 10/15/2025 ; 10149503 , exp 10/13/2025 ; 10149504 , exp 10/13/2025 ; 10149657 , exp 10/16/2025 ; 10149658 , exp 10/16/2025 ; 10149659 , exp 10/15/2025 ; 10150137 , exp 10/23/2025 ; 10150138 , exp 10/23/2025 ; 10150139 , exp 10/23/2025 ; 10150140 , exp 10/23/2025 ; 10149729 , exp 10/16/2025 ; 10149730 , exp 10/16/2025 ; 10149732 , exp 10/16/2025 ; 10149733 , exp 10/16/2025 ; 10149737 , exp 10/16/2025 ; 10149738 , exp 10/16/2025 ; 10149790 , exp 10/17/2025 ; 10149787 , exp 10/16/2025 ; 10149788 , exp 10/16/2025 ; 10149791 , exp 10/17/2025 ; 10149792 , exp 10/16/2025 ; 10149800 , exp 10/16/2025 ; 10149841 , exp 10/19/2025 ; 10149833 , exp 10/19/2025 ; 10149840 , exp 10/19/2025 ; 10149842 , exp 10/20/2025 ; 10149838 , exp 10/19/2025 ; 10149839 , exp 10/19/2025 ; 10149843 , exp 10/20/2025 ; 10149968 , exp 10/20/2025 ; 10149969 , exp 10/21/2025 ; 10150007 , exp 10/22/2025 ; 10150134 , exp 10/23/2025 ; 10150253 , exp 10/26/2025 ; 10150254 , exp 10/26/2025 ; 10150135 , exp 10/23/2025 ; 10150302 , exp 10/27/2025 ; 10150303 , exp 10/28/2025 ; 10150182 , exp 10/31/2025 ; 10150183 , exp 10/23/2025 ; 10150185 , exp 10/24/2025 ; 10150184 , exp 10/23/2025 ; 10150186 , exp 10/23/2025 ; 10150187 , exp 10/23/2025 ; 10150204 , exp 10/27/2025 ; 10150357 , exp 10/29/2025 ; 10150358 , exp 10/29/2025 ; 10150361 , exp 10/29/2025 ; 10150362 , exp 10/29/2025 ; 10150525 , exp 10/30/2025 ; 10150526 , exp 10/30/2025 ; 10150527 , exp 10/30/2025 ; 10150528 , exp 10/30/2025 ; 10150532 , exp 10/30/2025 ; 10150533 , exp 10/30/2025 ; 10150534 , exp 10/30/2025 ; 10150535 , exp 10/30/2025 ; 10150537 , exp 10/30/2025 ; 10150538 , exp 10/30/2025 ; 10150550 , exp 10/31/2025 ; 10150551 , exp 10/31/2025 ; 10150596 , exp 11/3/2025 ; 10150597 , exp 11/3/2025 ; 10150598 , exp 11/3/2025 ; 10150599 , exp 11/3/2025 ; 10150616 , exp 11/3/2025 ; 10150617 , exp 11/3/2025 ; 10150619 , exp 11/3/2025 ; 10150620 , exp 11/3/2025 ; 10150631 , exp 11/3/2025 ; 10150632 , exp 11/3/2025 ; 10150633 , exp 11/3/2025 ; 10150634 , exp 11/3/2025 ; 10150613 , exp 11/3/2025 ; 10150614 , exp 11/3/2025 ; 10150677 , exp 11/3/2025 ; 10150720 , exp 11/4/2025 ; 10150650 , exp 11/5/2025 ; 10150778 , exp 11/5/2025 ; 10150779 , exp 11/5/2025 ; 10150883 , exp 11/5/2025 ; 10151024 , exp 11/5/2025 ; 10151025 , exp 11/5/2025 ; 10150884 , exp 11/6/2025 ; 10151061 , exp 11/11/2025 ; 10151069 , exp 11/11/2025 ; 10150944 , exp 11/9/2025 ; 10150945 , exp 11/9/2025 ; 10151121 , exp 11/12/2025 ; 10151129 , exp 11/13/2025 ; 10150948 , exp 11/9/2025 ; 10150949 , exp 11/9/2025 ; 10151184 , exp 11/13/2025 ; 10151195 , exp 11/13/2025 ; 10150961 , exp 11/9/2025 ; 10150980 , exp 11/10/2025 ; 10150981 , exp 11/10/2025 ; 10150984 , exp 11/10/2025 ; 10150985 , exp 11/10/2025 ; 10151013 , exp 11/10/2025 ; 10151051 , exp 11/11/2025 ; 10151052 , exp 11/11/2025 ; 10151055 , exp 11/11/2025 ; 10151056 , exp 11/11/2025 ; 10151070 , exp 11/12/2025 ; 10151071 , exp 11/11/2025 ; 10151014 , exp 11/11/2025 ; 10151072 , exp 11/12/2025 ; 10151074 , exp 11/12/2025 ; 10151075 , exp 11/12/2025 ; 10151078 , exp 11/12/2025 ; 10151079 , exp 11/12/2025 ; 10151111 , exp 11/12/2025 ; 10151112 , exp 11/12/2025 ; 10151115 , exp 11/12/2025 ; 10151116 , exp 11/12/2025 ; 10151130 , exp 11/12/2025 ; 10151131 , exp 11/13/2025 ; 10151132 , exp 11/13/2025 ; 10151134 , exp 11/13/2025 ; 10151135 , exp 11/13/2025 ; 10151138 , exp 11/13/2025 ; 10151139 , exp 11/13/2025 ; 10151173 , exp 11/17/2025 ; 10151174 , exp 11/17/2025 ; 10151177 , exp 11/13/2025 ; 10151178 , exp 11/13/2025 ; 10151196 , exp 11/14/2025 ; 10151197 , exp 11/13/2025 ; 10151199 , exp 11/14/2025 ; 10151200 , exp 11/14/2025 ; 10151203 , exp 11/14/2025 ; 10151204 , exp 11/14/2025 ; 10151418 , exp 11/19/2025 ; 10151419 , exp 11/19/2025 ; 10151423 , exp 11/19/2025 ; 10151424 , exp 11/19/2025 ; 10151442 , exp 11/19/2025 ; 10151443 , exp 11/19/2025 ; 10151447 , exp 11/19/2025 ; 10151448 , exp 11/19/2025 ; 10151462 , exp 11/19/2025 ; 10151463 , exp 11/19/2025 ; 10151464 , exp 11/19/2025 ; 10151466 , exp 11/20/2025 ; 10151468 , exp 11/19/2025 ; 10151467 , exp 11/20/2025 ; 10151470 , exp 11/24/2025 ; 10151471 , exp 11/24/2025 ; 10151475 , exp 11/24/2025 ; 10151476 , exp 11/24/2025 ; 10151505 , exp 11/23/2025 ; 10151506 , exp 11/23/2025 ; 10151509 , exp 11/23/2025 ; 10151510 , exp 11/23/2025 ; 10151523 , exp 11/24/2025 ; 10151524 , exp 11/24/2025 ; 10151525 , exp 11/23/2025 ; 10151527 , exp 11/24/2025 ; 10151528 , exp 11/24/2025 ; 10151531 , exp 11/24/2025 ; 10151532 , exp 11/24/2025 ; 10151546 , exp 11/24/2025 ; 10151547 , exp 11/24/2025 ; 10151550 , exp 11/24/2025 ; 10151551 , exp 11/24/2025 ; 10151563 , exp 11/24/2025 ; 10151564 , exp 11/24/2025 ; 10151567 , exp 11/24/2025 ; 10151568 , exp 11/24/2025 ; 10151580 , exp 11/24/2025 ; 10151581 , exp 11/24/2025 ; 10151582 , exp 11/24/2025 ; 10151584 , exp 11/25/2025 ; 10151585 , exp 11/25/2025 ; 10151588 , exp 11/25/2025 ; 10151589 , exp 11/25/2025 ; 10151600 , exp 11/25/2025 ; 10151601 , exp 11/25/2025 ; 10151604 , exp 11/25/2025 ; 10151605 , exp 11/25/2025 ; 10151705 , exp 11/25/2025 ; 10151706 , exp 11/25/2025 ; 10151707 , exp 11/25/2025 ; 10151711 , exp 11/26/2025 ; 10151727 , exp 11/26/2025 ; 10151728 , exp 11/25/2025 ; 10151729 , exp 11/25/2025 ; 10151770 , exp 11/26/2025 ; 10151771 , exp 11/27/2025 ; 10151788 , exp 11/26/2025 ; 10151789 , exp 11/26/2025 ; 10151969 , exp 12/2/2025 ; 10151979 , exp 12/1/2025 ; 10151980 , exp 12/1/2025 ; 10151970 , exp 12/2/2025 ; 10151981 , exp 12/2/2025 ; 10151982 , exp 12/1/2025 ; 10151971 , exp 12/2/2025 ; 10152008 , exp 12/2/2025 ; 10152009 , exp 12/2/2025 ; 10152010 , exp 12/3/2025 ; 10152060 , exp 12/3/2025 ; 10152061 , exp 12/9/2025 ; 10152011 , exp 12/2/2025 ; 10152121 , exp 12/4/2025 ; 10152122 , exp 12/4/2025 ; 10152012 , exp 12/3/2025 ; 10152064 , exp 12/4/2025 ; 10152123 , exp 12/4/2025 ; 10152124 , exp 12/5/2025 ; 10152178 , exp 12/7/2025 ; 10152062 , exp 12/4/2025 ; 10152175 , exp 12/7/2025 ; 10152179 , exp 12/8/2025 ; 10152180 , exp 12/8/2025 ; 10152063 , exp 12/4/2025 ; 10152176 , exp 12/7/2025 ; 10152177 , exp 12/7/2025 ; 10152323 , exp 12/9/2025 ; 10152339 , exp 12/9/2025 ; 10152374 , exp 12/11/2025 ; 10152340 , exp 12/10/2025 ; 10152341 , exp 12/10/2025 ; 10152375 , exp 12/11/2025 ; 10152371 , exp 12/10/2025 ; 10152372 , exp 12/10/2025 ; 10152376 , exp 12/11/2025 ; 10152373 , exp 12/10/2025 ; 10152393 , exp 12/11/2025 ; 10152428 , exp 12/11/2025 ; 10152394 , exp 12/11/2025 ; 10152395 , exp 12/10/2025 ; 10152429 , exp 12/12/2025 ; 10152774 , exp 12/16/2025 ; 10152775 , exp 12/16/2025 ; 10152834 , exp 12/21/2025 ; 10152835 , exp 12/21/2025 ; 10152861 , exp 12/22/2025 ;
- Distribution
- U.S. Nationwide
- Quantity
- 75,885 syringes
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0113-2026
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Class II Ongoing
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical 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
- Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical 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-0784-2023
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.