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.
1,070 recalls
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Class II Ongoing
EXCEDRIN 2'S DISP.- 30 CT
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0269-2026
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Class II Ongoing
LIQUID DAYQUIL 12/8oz
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0268-2026
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Class II Ongoing
DAYQUIL COLD & FLU, 32CT/2PK
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- Unknown
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0267-2026
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Class II Ongoing
Claritin, 20 Count, UPC: 655708016305
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- Unknown
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0266-2026
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Class II Ongoing
Bayer 2Pk- 25 CT
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0265-2026
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Class II Ongoing
Benadryl, 25'S 2PK Box, UPC 815556020316
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0264-2026
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Class II Ongoing
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Product
- Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- Unknown
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0263-2026
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Class II Ongoing
Aleve 1's, 60 CT
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0262-2026
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Class II Ongoing
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- Unkown
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0261-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Reason: Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Lots, distribution and details
- Lots / codes
- Lot # MHA21825, Exp Date: December 31, 2027
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- December 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0259-2026
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Class I Ongoing
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- Nationwide in the US
- Quantity
- —
- Recall started
- December 12, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0289-2026
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Class I Ongoing
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- Nationwide in the US
- Quantity
- —
- Recall started
- December 12, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0288-2026
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Class III Ongoing
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Lots, distribution and details
- Lots / codes
- Lot # EA00237A, Exp Date: 04/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- 2,136 1000-count bottles
- Recall started
- December 19, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0247-2026
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Class II Ongoing
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., L…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10
- Lots / codes
- Lot: D05004E, expires: 04-30-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 1,636 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-0234-2026
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Class II Ongoing
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 29…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.
- Lots / codes
- Lot: D05159H, expires: 07-31-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- 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-0232-2026
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Class III Ongoing
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Lots, distribution and details
- Lots / codes
- Lot # F2400244, Exp Date: 10/31/2026
- Distribution
- Distributed Nationwide
- Quantity
- 4800 54-count bottles
- Recall started
- November 11, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0219-2026
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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
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 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
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
-
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
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Class II Ongoing
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
Reason: Microbial contamination of a non-sterile product – microorganism found to be pseudomonas lactis
Lots, distribution and details
- Lots / codes
- Lot#: 71409, Expires: 02/28/2027; 71861, Expires: 08/31/2027.
- Distribution
- Nationwide USA
- Quantity
- 41,328 bottles
- Recall started
- November 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0179-2026
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 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.