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
-
Class II Ongoing
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Reason: Defective Container: Product has incomplete induction seals.
Lots, distribution and details
- Lots / codes
- Lot# 379804, Exp. 8/31/2023
- Distribution
- Nationwide USA
- Quantity
- 14,712 bottles
- Recall started
- August 1, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1361-2022
-
Class III Ongoing
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmac…
Reason: Defective Container: Tube split from side seam
Lots, distribution and details
- Product
- Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
- Lots / codes
- Lot #s: a) 15200058, 15200066, 15200067, Exp 06/2022; 15200075, Exp 07/2022; 15200094, Exp 08/2022; 15200119, 15200120, 15200122, Exp 09/2022; 15200131, 15200132, Exp 10/2022; 15200133, 15200134, 15200136, 15200139, Exp 11/2022; 15210033, 15210035, 15210036, 15210038 Exp 01/2023; 15210092, 15210094, 15210097, 15210099, Exp 03/2023; 15210100, 15210101, 15210104, Exp 04/2023; 15210122, Exp 05/2023; 15210148, 15210149, 15210153, 15210155, 15210157, 15210158, Exp 06/2023; 15210173, 15210174, 15210176, 15210177, 15210178, 15210179, Exp 07/2023; 15210184, 15210186, Exp 08/2023; 15210214, Exp 09/2023; 15210225, 15210226, 15210228, 15210230, 15210231, Exp 10/2023; 15220001, 15220002, Exp 12/2023. b) 15200092, Exp 08/2022; 15200114, 15200115, Exp 09/2022; 15200123, 15200124, Exp 10/2022; 15200142, 15200144, Exp 11/2022; 15210014, 15210015, 15210021, Exp 12/2022; 15210031, Exp 01/2023; 15210055, Exp 02/2023; 15210073, 15210075, Exp 03/2023; 15210117, 15210118, Exp 04/2023; 15210144, 15210147, 15210160, 15210162, Exp 06/2023; 15210171, Exp 07/2023; 15210187, 15210190, 15210191, 15210193, Exp 08/2023; 15210212, Exp 09/2023; 15210244, 15210247, Exp 11/2023; 15220007, Exp 12/2023; 15220019, 15220028, Exp 01/2024; 15220032, 15220034, 15220053, Exp 02/2024; 15220062, 15220064, 15220072, Exp 03/2024. c) 15200065, Exp 06/2022; 15200108, 15200109, Exp 09/2022; 15200125, Exp 10/2022; 15200148, 15200149, 15200150, Exp 11/2022; 15210007, 15210009, 15210012, 15210018, Exp 12/2022; 15210049, Exp 02/2023; 15210076, 15210077, 15210089, Exp 03/2023; 15210112, 15210114, Exp 04/2023; 15210124, 15210125, 15210127, Exp 05/2023; 15210169, 15210170, Exp 07/2023; 15210196, 15210199, Exp 08/2023; 15210204, 15210206, 15210207, 15210210, Exp 09/2023; 15210248, Exp 11/2023; 15220004, 15220013, 15220014, 15220015, Exp 12/2023; 15220025, 15220026, Exp 01/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 654,756 tubes
- Recall started
- July 11, 2022 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-1304-2022
-
Class III Ongoing
Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.
Reason: Failed Tablet/Capsule Specification : Capsule breakage
Lots, distribution and details
- Lots / codes
- Lot#: 17201639, Exp 08/2022; 17201759, Exp 09/2022; 17202067, Exp 10/2022; 17210696, Exp 02/2023; 17210092, Exp 11/2022; 17210145, Exp 12/2022; 17210732, Exp 02/2023; 17211062, Exp 04/2023; 17211441, Exp 05/2023; 17211670, Exp 06/2023; 17211810, Exp 07/2023; 17211862, 17212020, 17212068, Exp 08/2023; 17212438, Exp 10/2023; 17220172, 17220251, Exp 12/2023.
- Distribution
- USA Nationwide
- Quantity
- 168936 bottles
- Recall started
- June 29, 2022 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-1282-2022
-
Class II Ongoing
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a) 01122204A1, Exp 4/12/2022; 02192214A1, Exp 5/20/2022; b) 12142122A2, Exp. 3/14/2022; 12282118A2, Exp 3/28/2022; 01112203A1, Exp 4/11/2022; 01122208A1, Exp 4/12/2022; 01202211A2, Exp 4/20/2022; 02032205A1, Exp 5/4/2022; 02192212A1, Exp 5/20/2022; 03042201A1, Exp 6/2/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 485 Vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1243-2022
-
Class II Ongoing
Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 02252201A1, Exp 4/15/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 15 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1242-2022
-
Class II Ongoing
Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 03112233B, Exp 5/10/2022
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 6 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1241-2022
-
Class II Ongoing
Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a) 01252201A2, Exp 3/26/2022; b) 01252201A2, Exp 3/26/2022; 02032213A2, Exp 4/4/2022; 03042209A1, Exp 5/3/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 75 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1240-2022
-
Class II Ongoing
Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
- Lots / codes
- Batch#: 12012123A2, Exp 5/30/2022; 01312212A1, Exp 7/30/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 64 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1239-2022
-
Class II Ongoing
Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a)10142117A2, Exp 4/12/2022; 10272108A1, Exp 4/25/2022; 11302113A2, Exp 5/29/2022; 02252220A1, Exp 8/24/2022; b)10142108A2, Exp 4/12/2022; 12072134A1, Exp 6/5/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 414 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1238-2022
-
Class II Ongoing
Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
- Lots / codes
- Batch#: 11102106A1, Exp 4/30/2022; 01142230A1, Exp 7/13/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 93 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1237-2022
-
Class II Ongoing
Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a)11042102A1, Exp 4/30/2022; 12072135A1, Exp 6/5/2022, 01142228A1, Exp 7/13/2022; 02182231A1, Exp 8/17/2022; b)11042102A1, Exp 4/30/2022; 01142228A1, Exp 7/13/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 176 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1236-2022
-
Class II Ongoing
Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
- Lots / codes
- Batch#: a) 10202107A1, Exp 4/18/2022; b) 10142120A2, Exp 4/12/2022; 10272102A1, Exp 4/25/2022 ; 11032117A2, 11102104A2, Exp 4/30/2022; 01252212A2 , Exp 7/24/2022; 02182227A1, Exp 8/17/2022 .
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 246 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1235-2022
-
Class II Ongoing
Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
- Lots / codes
- Batch#: Expiry: a) 01142227A1, Exp 7/13/2022; b) 12012126A2, Exp 5/30/2022; 02042203A1, Exp 8/3/2022; c) 01052207A1, Exp 7/4/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 58 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1234-2022
-
Class II Ongoing
Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a)10142123A2, Exp 4/12/2022, 02042202A1, Exp 8/3/2022; b) 10142121A2, Exp 4/12/2022; 10202105A1, Exp 4/18/2022; 11102102A1, Exp 4/30/2022; 02042202A1, Exp 8/3/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 106 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1233-2022
-
Class II Ongoing
Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 11232117A1, Exp 5/22/2022; 01312215A1, Exp 7/30/2022
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 41 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1232-2022
-
Class II Ongoing
Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a)12212105A2, Exp 6/19/2022; 02182229A1, Exp 8/17/2022; b) 12012121A2, Exp 5/30/2022; 12212104A2, Exp 6/19/2022; 01242216A2, Exp 7/23/2022; 02182236A1, Exp 8/17/2022; c) 12072133A1, Exp 6/5/2022; 01192225A1, Exp 7/18/2022; 02182228A1, Exp 8/17/2022; d)10142105A, Exp 4/12/2022; 10272105A1, Exp 4/25/2022; 11102101A1, 11032120A2, Exp 4/30/2022; 11222116A2, Exp 5/21/2022; 12012121A2, Exp 5/30/2022; 12072132A1, Exp 6/5/2022; 12152110A1, Exp 6/13/2022; 12162118A1, Exp 6/14/2022; 12212103A2, Exp 6/19/2022; 01052206A1, Exp 7/4/2022; 01142229A1, Exp 7/13/2022; 01212207A2 Exp, 7/20/2022; 02042201A1, Exp 8/3/2022; 02182226A1, Exp 8/17/2022; 02252224A1, 02252226A1, Exp 8/24/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 4,219 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1231-2022
-
Class II Ongoing
Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a) 12212109A2, Exp 6/19/2022; 01312217A1, Exp 7/30/2022; b) 10202108A1, Exp 4/18/2022; 12012125A, Exp 5/30/2022 ;02182230A1, Exp 8/17/2022; 10202108A1; 03022222A1, Exp 8/29/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 273 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1230-2022
-
Class II Ongoing
Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 01132208A1, Exp 4/13/2022; 02252205A1, Exp 5/26/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 12 syringes
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1229-2022
-
Class II Ongoing
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch #: 10122102A2, Exp 3/22/2022; 10252101A2, Exp 3/24/2022; 11092106A2, Exp 4/8/2022; 11232102A1, Exp 5/7/2022; 11162106A1, Exp 5/15/2022; 12032114A1, 02212224A1, Exp 5/22/2022; 12142111A1, 12202109A2, Exp 5/24/2022; 03032244A1, Exp 6/1/2022; 03082209A1, Exp 6/6/2022; 12292116A2, Exp 6/27/2022; 01182204A1, 01262232A1, 01262233A1, Exp 6/30/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 2,870 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1228-2022
-
Class II Ongoing
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 11102107A2, Exp 4/9/202211232104A1, Exp 5/7/2022; 02212229A1, 11292103A2, Exp 5/22/2022; 12132105A2, Exp 5/24/2022; 02282207A1, Exp 5/29/2022; 03082209A1, Exp 6/6/2022; 03112231B, Exp 6/9/2022; 01042212A1, Exp 6/27/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 1,562 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1227-2022
-
Class II Ongoing
Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 10122103A2, Exp 3/22/2022; 11092108A2, Exp 4/30/2022; 11192115A2, Exp 5/7/2022; 12022107A2, Exp 5/22/2022; 12132107A2, Exp 5/24/2022; 01182201A2, Exp 6/30/2022; 02142212A1, Exp 8/13/2022; 03022217A1, Exp 8/29/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 1,208 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1226-2022
-
Class II Ongoing
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
- Lots / codes
- Batch#: 12092115A2, Exp 3/9/2022; 12162116A2, Exp 3/16/2022; 12212106A2, Exp 3/21/2022; 01062219B, Exp 4/6/2022; 01072205A1, 01072208A1, Exp 4/7/2022; 01102203A1, Exp 4/10/2022; 01132207A1, Exp 4/13/2022; 01192216A1, Exp 4/19/2022; 01202204A2, Exp 4/20/2022; 01272223A2, Exp 4/27/2022; 01312219A2, Exp 5/1/2022; 02032204A2, Exp 5/4/2022; 02072203A1, Exp 5/8/2022; 02182216A1, 02182224A1, Exp 5/19/2022; 02232202A1, 02232210A1, Exp 5/24/2022; 02242202A1, 02242203A1, 02242235A1, 02242238A1, Exp 5/25/2022; 03072217A1, 03072223A1, Exp 6/5/2022; 03082223A1, 03082229A1, Exp 6/6/2022; 03092207A1, 03092219A1, Exp 6/7/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 9,993 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1225-2022
-
Class II Ongoing
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
- Lots / codes
- Batch#: 12032123A2, Exp 3/3/2022; 12102101A2, Exp 3/10/2022; 12202105A2, Exp 3/20/2022; 12292106A2, Exp 3/29/2022; 01062218B, Exp 4/6/2022; 01192228A2, Exp 4/19/2022; 01312214A2, Exp 5/1/2022; 02012211A1, Exp 5/2/2022; 02182201A1, 02182203A1, Exp 5/19/2022; 02242205A1, 02242206A1, Exp 5/25/2022; 03072209A1, Exp 6/5/2022; 03092203A1, 03092206A1, Exp 6/7/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 5,842 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1224-2022
-
Class II Ongoing
PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a) 01042226A2, Exp 4/4/2022; 01242228A2, Exp 4/24/2022; 02212208A1, Exp 5/22/2022; b) 01192230A2, Exp 4/19/2022; 02212217A1, Exp 5/22/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 392 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1223-2022
-
Class II Ongoing
Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: 10112102A2, Exp 4/9/2022; 11302101A1, Exp 5/29/2022; 01242201A1, Exp 5/31/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 58 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1222-2022
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.