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.
11 recalls
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Class II Ongoing
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.
- Lots / codes
- Lot#: 5KA0405, Exp 12/31/2026.
- Distribution
- USA Nationwide.
- Quantity
- N/A
- Recall started
- September 18, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0014-2027
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Class II Ongoing
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Reason: Failed stability specifications
Lots, distribution and details
- Lots / codes
- Lot#: TRIS -E04-0226-0016; Exp 2/29/28
- Distribution
- CA
- Quantity
- 200 kg
- Recall started
- July 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0012-2027
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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
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Tela…
Reason: Presence of Particulate Matter: Particulate matter identified as glass
Lots, distribution and details
- Product
- Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana – 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
- Lots / codes
- Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- October 1, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0036-2026
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Class II Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lots, distribution and details
- Lots / codes
- Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
- Distribution
- Nationwide in the US
- Quantity
- 493,468 bottles
- Recall started
- September 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0677-2025
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Class II Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch TZ1236, Exp Date: 11/30/2025
- Distribution
- US Nationwide.
- Quantity
- 87,840 bottles
- Recall started
- May 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0494-2025
-
Class II Ongoing
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippan…
Reason: Failed Impurities/Degradation Specification: Out of specification for organic impurities
Lots, distribution and details
- Product
- Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
- Lots / codes
- lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 71,244 sachets
- 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-0339-2024
-
Class II Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured 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-0813-2023
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Class II Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Ako…
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
- Lots / codes
- Lot: (a) 1A09A, EXP 12/31/2022; 1H01A, EXP 7/31/2023 ; (b) 1E32A, EXP 4/30/2023; 1F45A, EXP 5/31/2023; 1H99A, EXP 7/31/2023; 1K84A, EXP 9/30/2023; (c) 0L40A, EXP 10/31/2022; 1B38A, EXP 1/31/2023; 1E12A, EXP 4/30/2023; 1F41A, EXP 5/31/2023; 1G73A, 1G68A, EXP 6/30/2023; 1H08A, 1H12A, EXP 7/31/2023
- Distribution
- Nationwide in the USA
- Quantity
- 314,543 10ml,3ml, 5ml 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-0141-2023
-
Class II Ongoing
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 — NDC 0409-3796-01 —- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
Reason: Crystallization; identified as calcium salt of Ketorolac
Lots, distribution and details
- Lots / codes
- 31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015
- Distribution
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Recall started
- June 30, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1242-2015
-
Class II Ongoing
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 — NDC 0409-3795-01 — Also labeled under NOVAPLUS label NDC 0409-3795-49
Reason: Crystallization; identified as calcium salt of Ketorolac
Lots, distribution and details
- Lots / codes
- 31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016
- Distribution
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Quantity
- 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
- Recall started
- June 30, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1241-2015
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.