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.
3,228 recalls
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Class II Ongoing
Lanthanum Carbonate chewable tablets, 1000mg*, 10×9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boule…
Reason: Failed stability specifications: Out of specification for hardness test
Lots, distribution and details
- Product
- Lanthanum Carbonate chewable tablets, 1000mg*, 10×9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
- Lots / codes
- lot# NB240315, exp 12/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1180 boxes
- Recall started
- October 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0217-2026
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Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkel…
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
- Lots / codes
- Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
- Distribution
- Nationwide within the United States
- Quantity
- 7389 bottles
- Recall started
- November 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0216-2026
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Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC…
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
- Lots / codes
- Lot #: 240947C, 240962C, Exp. Date 04/2027
- Distribution
- Nationwide within the United States
- Quantity
- 3397 bottles
- Recall started
- November 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0215-2026
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Class II Ongoing
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LL…
Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Lots, distribution and details
- Product
- Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
- Lots / codes
- Lot 25381993 and 25391516, Exp 12/31/2026
- Distribution
- Distributed in Massachusetts
- Quantity
- 800 1mL vials
- 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-0214-2026
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Class II Ongoing
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A482305
- Distribution
- USA Nationwide
- Quantity
- 2400 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0213-2026
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Class II Ongoing
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A502404, Exp. Date 2/27; A502405, Exp. Date 2/27; AS02502, Exp. Date 2/28.
- Distribution
- USA Nationwide
- Quantity
- 33000 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0212-2026
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Class II Ongoing
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A472418
- Distribution
- USA Nationwide
- Quantity
- 14700 bottles
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0211-2026
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Class II Ongoing
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A472408
- Distribution
- USA Nationwide
- Quantity
- 12150 bottles
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0210-2026
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Class II Ongoing
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A352505
- Distribution
- USA Nationwide
- Quantity
- 7920 bottles
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0209-2026
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Class II Ongoing
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A352405
- Distribution
- USA Nationwide
- Quantity
- 13536 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0208-2026
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Class II Ongoing
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A092421, Exp. Date 7/27, A092340, Exp. Date 10/26 & A092346, Exp. Date 11/26.
- Distribution
- USA Nationwide
- Quantity
- 7944 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0207-2026
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Class II Ongoing
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A352318
- Distribution
- USA Nationwide
- Quantity
- 912 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0206-2026
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Class II Ongoing
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27
- Distribution
- USA Nationwide
- Quantity
- 2592 bottles
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0205-2026
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Class II Ongoing
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A322301, Exp. Date 7/26 & A322302, Exp. Date 8/26
- Distribution
- USA Nationwide
- Quantity
- 8184 bottles
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0204-2026
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Class II Ongoing
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
Reason: cGMP deviations
Lots, distribution and details
- Product
- Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
- Lots / codes
- Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27
- Distribution
- USA Nationwide
- Quantity
- 18912 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0203-2026
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Class II Ongoing
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
Reason: cGMP deviations
Lots, distribution and details
- Product
- Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
- Lots / codes
- Lot #: A092334, Exp. Date 6/26 & A092421, Exp. Date 7/27
- Distribution
- USA Nationwide
- Quantity
- 1560 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0202-2026
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Class II Ongoing
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
Reason: cGMP deviations
Lots, distribution and details
- Lots / codes
- Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.
- Distribution
- USA Nationwide
- Quantity
- 9600 containers
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0201-2026
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Class II Ongoing
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
- Distribution
- MO
- Quantity
- 858 syringes
- Recall started
- September 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0200-2026
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Class III Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manu…
Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Lots, distribution and details
- Product
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
- Lots / codes
- Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
- Distribution
- Nationwide in the USA
- Quantity
- 11,136 bottles
- Recall started
- November 21, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0199-2026
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Class III Ongoing
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ…
Reason: Defective Container – A defect in the side-seal which allows leakage of product.
Lots, distribution and details
- Product
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
- Lots / codes
- Lot #100068692, Exp.: 04/30/2027
- Distribution
- U.S. Nationwide
- Quantity
- 15,944 cartons
- Recall started
- November 7, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0198-2026
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Class II Ongoing
Phytonadione Injectable Emulsion, USP 10mg/mL, 10×1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097…
Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index
Lots, distribution and details
- Product
- Phytonadione Injectable Emulsion, USP 10mg/mL, 10×1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
- Lots / codes
- Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
- Distribution
- Nationwide in the USA
- Quantity
- 4,438 10x1mL cartons
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0197-2026
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Class II Ongoing
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
- Lots / codes
- Lot D54947, exp 4/30/2028
- Distribution
- CA, CO, FL, PR, WA
- Quantity
- 4890 bottles
- 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-0196-2026
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Class II Ongoing
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
Reason: CGMP Deviations
Lots, distribution and details
- Product
- CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
- Lots / codes
- Lot D54447, exp 11/30/2027
- Distribution
- CA, CO, FL, PR, WA
- Quantity
- 4890 bottles
- 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-0195-2026
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Class II Ongoing
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
- Lots / codes
- Lot D53681, exp 03/31/2027
- Distribution
- CA, CO, FL, PR, WA
- Quantity
- N/A
- 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-0194-2026
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Class II Ongoing
Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
- Lots / codes
- Lot D53682, exp 3/31/2027
- Distribution
- CA, CO, FL, PR, WA
- Quantity
- 3295 bottles
- 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-0193-2026
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 1, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.