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.
3,222 recalls
-
Class II Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Reason: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Lots, distribution and details
- Lots / codes
- Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026
- Distribution
- Nationwide in the USA.
- Quantity
- 10,620 – 200 mL 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-0469-2025
-
Class II Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Reason: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Lots, distribution and details
- Lots / codes
- Lot #: 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 48,936 – 100 mL 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-0468-2025
-
Class I Ongoing
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
- Distribution
- Nationwide
- Quantity
- 300 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0467-2025
-
Class I Ongoing
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
- Distribution
- Nationwide
- Quantity
- 500 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0466-2025
-
Class I Ongoing
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
- Distribution
- Nationwide
- Quantity
- 300 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0465-2025
-
Class I Ongoing
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
- Distribution
- Nationwide
- Quantity
- 500 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0464-2025
-
Class I Ongoing
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Lots, distribution and details
- Lots / codes
- All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027
- Distribution
- Nationwide
- Quantity
- 3000 boxes
- Recall started
- April 14, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0463-2025
-
Class III Ongoing
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceutica…
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Lots, distribution and details
- Product
- Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
- Lots / codes
- Lot #: 17240195, Exp 01/31/2026.
- Distribution
- Nationwide USA and PR
- Quantity
- 6,759 Con – 90 bottle pack
- Recall started
- May 19, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0462-2025
-
Class II Ongoing
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5×10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot # 47947, Exp 05/31/2026
- Distribution
- Nationwide USA
- Quantity
- 962 cartons
- Recall started
- May 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0461-2025
-
Class II Ongoing
Celecoxib Capsules, 200 mg, 50 Capsules (5×10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Reason: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Lots, distribution and details
- Product
- Celecoxib Capsules, 200 mg, 50 Capsules (5×10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
- Lots / codes
- Lot #47881, Exp 05/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 3,817 50-count cartons
- Recall started
- May 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0460-2025
-
Class II Ongoing
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster,…
Reason: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Lots, distribution and details
- Product
- Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
- Lots / codes
- Batch 2405014780, Exp. Date: Sep. 30, 2027
- Distribution
- Distributed Nationwide and in PR
- Quantity
- 2,946 500-count bottles
- Recall started
- May 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0459-2025
-
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
-
Class II Ongoing
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
Reason: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Lots, distribution and details
- Lots / codes
- Batch # TZ5589, Exp Date: 01/31/2026
- Distribution
- US Nationwide.
- Quantity
- 20,648 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-0457-2025
-
Class II Completed
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4×7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Cart…
Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lots, distribution and details
- Product
- Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4×7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
- Lots / codes
- Lot# BDX6K001; Exp. Date: 06/30/2025
- Distribution
- U.S. Nationwide.
- Quantity
- 972 Cartons
- Recall started
- May 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0456-2025
-
Class II Completed
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lots, distribution and details
- Product
- Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
- Lots / codes
- Lot# BDX6K001; Exp. Date 06/30/2025
- Distribution
- U.S. Nationwide.
- Quantity
- 3672 Bottles
- Recall started
- May 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0455-2025
-
Class II Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (bl…
Reason: cGMP deviations
Lots, distribution and details
- Product
- Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
- Lots / codes
- Lot #: 1021950, Exp. 11/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 21 cartons
- 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-0454-2025
-
Class I Ongoing
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement….rgy and Endurance, UPC X004BB9Z8N
Reason: Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Lots, distribution and details
- Product
- ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement….rgy and Endurance, UPC X004BB9Z8N
- Lots / codes
- Lot: 250214PRO, Expiration Date: 02/14/2027.
- Distribution
- Nationwide Via Amazon Platform
- Quantity
- 600, 20-count cartons
- Recall started
- May 6, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0453-2025
-
Class II Ongoing
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa – 403513, India. Manufactured for: Glenmark Pharmaceutica…
Reason: OOS results reported for the Dissolution (by UV) test.
Lots, distribution and details
- Product
- Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa – 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
- Lots / codes
- Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
- Distribution
- Nationwide in the USA
- Quantity
- 8,520 100-count bottles
- 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-0452-2025
-
Class II Ongoing
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots, distribution and details
- Lots / codes
- Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
- Distribution
- U.S. Nationwide
- Quantity
- 18,696 bottles
- Recall started
- February 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0451-2025
-
Class II Ongoing
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots, distribution and details
- Product
- Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
- Lots / codes
- Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25
- Distribution
- U.S. Nationwide
- Quantity
- 84,048 bottles
- Recall started
- February 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0450-2025
-
Class II Ongoing
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., US…
Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots, distribution and details
- Product
- Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Lots / codes
- [100-Count Bottles] Lot 19231618, exp Mar-25; 19232064, exp Apr-25; 19232324, May-25; 19233369, Exp Jul-25; Lot 19234162, Exp Sep-25; Lot 19240543, Exp Jan-26 [500-Count Bottles] Lots 19231174, 19231199, 19231164, Exp Feb-25, 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,19231638, 19231448, Exp Mar-25, 19232043,19232051,19232064, Apr-25, 19232322, 19232324, 19232365, 19232380, 19232389, Exp May-25; Lots 19232736, 19232743, 19232746, 19232756, 19232757, Exp Jun-25; Lots 19233369, 19233371, 19233405, 19233416, Exp Jul-25; Lots 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242, Exp Sep-25; Lots 19234743, 19234774, 19234993, Exp Nov-25; Lots 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319, Exp Dec-25; Lot 19240543, Exp Jan-26
- Distribution
- U.S. Nationwide
- Quantity
- [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles
- Recall started
- February 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0449-2025
-
Class II Ongoing
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals…
Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots, distribution and details
- Product
- Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Lots / codes
- [100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lots 19234843, 19235039, Exp Nov-25; Lots 19240280, 19240296, Dec-25
- Distribution
- U.S. Nationwide
- Quantity
- [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
- Recall started
- February 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0448-2025
-
Class II Ongoing
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
- Lots / codes
- Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
- Distribution
- US Nationwide
- Quantity
- N/A
- Recall started
- May 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0447-2025
-
Class II Ongoing
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot#: 18350A, 18351A, Exp 6/30/2027
- Distribution
- Nationwide
- Quantity
- 9680 bottles
- Recall started
- May 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0446-2025
-
Class II Ongoing
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot#: 18400A, Exp 7/31/2027
- Distribution
- Nationwide
- Quantity
- 9107 bottles
- Recall started
- May 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0445-2025
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 2, 2026 14:41. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.