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
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Class II Ongoing
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured f…
Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Lots, distribution and details
- Product
- ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.
- Lots / codes
- Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
- Distribution
- FL
- Quantity
- 37,500 Boxes
- Recall started
- February 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0247-2025
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Class II Completed
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Reason: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Lots, distribution and details
- Lots / codes
- Lot # 193109; Exp. 07/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 4944 cartons
- Recall started
- February 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0246-2025
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Class I Ongoing
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA…
Reason: Defective delivery system – patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Lots, distribution and details
- Product
- Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
- Lots / codes
- Lot #: 108319, Exp: 04/30/2027
- Distribution
- USA Nationwide
- Quantity
- 112,128 cartons (5 pouches/carton)
- Recall started
- January 31, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0245-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 58,368 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0244-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 58,416 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0243-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 53,952 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0242-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 233,040 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0241-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 133,824 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0240-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 119,040 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0239-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 120,000 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0238-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 39,168 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0237-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19234153, Exp.: 9/2025; 19234900, 19234929, Exp.: 11/2025; 19240936, 19240942, Exp.: 2/2026; 19243199, 19243190, Exp.:7/2026; 19244013, 19244014, Exp.: 9/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 87,600 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0236-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 80,160 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0235-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 190,320 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0234-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 175,920 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0233-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 56,208 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0232-2025
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Class II Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 70,032 bottles
- Recall started
- January 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0231-2025
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Class I Ongoing
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
Reason: Presence of Particulate Matter.
Lots, distribution and details
- Lots / codes
- Lot# 24020027, Exp Date: 12/31/2025
- Distribution
- Nationwide in the U.S.
- Quantity
- 24640 vials
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0230-2025
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Class II Ongoing
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
Reason: Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Lots, distribution and details
- Lots / codes
- Lot#: BC20223A, Exp. March 31, 2025.
- Distribution
- USA Nationwide
- Quantity
- 1266 bottles
- Recall started
- February 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0229-2025
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Class II Ongoing
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major…
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lots, distribution and details
- Product
- Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
- Lots / codes
- Lot #s: N01422, N01423, Exp 03/31/2025; N01661, N01662, Exp 09/30/2025; N01746, N01750, Exp 10/31/2025; N01876, N01877, Exp 03/31/2026; N01899, N01900, N01975, Exp 04/30/2026.
- Distribution
- Nationwide U.S. and Puerto rico
- Quantity
- 27,525 cartons
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0228-2025
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Class II Ongoing
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major…
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lots, distribution and details
- Product
- Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
- Lots / codes
- Lot #s: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, Exp 08/31/2026.
- Distribution
- Nationwide U.S. and Puerto rico
- Quantity
- 94,349 cartons
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0227-2025
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Class II Ongoing
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Maj…
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lots, distribution and details
- Product
- Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
- Lots / codes
- Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026.
- Distribution
- Nationwide U.S. and Puerto rico
- Quantity
- 82,281 cartons
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0226-2025
-
Class II Completed
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
- Lots / codes
- Lot # C274-000040409, Exp 03/22/2025
- Distribution
- Distributed in PA
- Quantity
- 1330 bags
- Recall started
- January 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0225-2025
-
Class II Ongoing
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Reason: Out of Specification for Dissolution
Lots, distribution and details
- Lots / codes
- Lot 45279, Exp 03/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 341 cartons
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0224-2025
-
Class I Ongoing
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Reason: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- USA nationwide.
- Quantity
- 44,397 amber glass vials
- Recall started
- December 20, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0223-2025
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 3, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.