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
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
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
Reason: cGMP deviations.
Lots, distribution and details
- Lots / codes
- Lot #: 239066, Exp. Date 1/24/2027; 378106, Exp. Date 3/8/2026; 379202, Exp. Date 3/29/2026; 379750, Exp. Date 4/24/2026; 380983, Exp. Date 5/24/2026; 382901, Exp. Date 7/11/2026; 384682, Exp. Date 8/16/2026; 386189, Exp. Date 9/20/2026; 387559, Exp. Date 10/11/2026; 388381, Exp. Date 11/2/2026; 398066, Exp. Date 1/24/2027; 389477, Exp. Date 2/21/2027; 392491, Exp. Date 3/13/2027; 393724, Exp. Date 4/3/2027, 394683, Exp. Date 4/29/2027; 395094, Exp. Date 5/29/2027; 395231, Exp. Date 6/18/2027; 395368, Exp. Date 7/17/2027, 397971, Exp. Date 11/8/2027; 398930, Exp. Date 8/28/2027; 399204, Exp. Date 9/25/2027; 400300, Exp. Date 10/16/2027; 403177, Exp. Date 11/8/2027; 403314, Exp. Date 11/25/2027; 405095, Exp. Date 1/24/2028; 406328, Exp. Date 2/14/2028; 407700, Exp. Date 4/3/2028; 407974, Exp. Date 4/17/2028; ; 410166, Exp. Date 6/13/2028; 410988, Exp. Date 7/1/2028.
- Distribution
- Nationwide within the United States
- Quantity
- 7677 bags
- Recall started
- January 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0260-2026
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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 II Ongoing
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Lots, distribution and details
- Lots / codes
- Lot #: P-22-3, Exp 06-2027
- Distribution
- GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
- Quantity
- 22,843 pellets
- Recall started
- October 3, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0258-2026
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Class III Ongoing
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 1…
Reason: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Lots, distribution and details
- Product
- Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
- Lots / codes
- Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
- Distribution
- Nationwide in the USA.
- Quantity
- —
- Recall started
- November 26, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0257-2026
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Class III Ongoing
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Lots, distribution and details
- Lots / codes
- Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
- Distribution
- Nationwide within the USA
- Quantity
- 24,624 bottles
- Recall started
- December 30, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0256-2026
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Class II Ongoing
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Reason: Out of specification for dissolution.
Lots, distribution and details
- Product
- Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
- Lots / codes
- Lot #49124, Exp Date 12/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 7,991 5×10 cartons
- 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-0292-2026
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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 II Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Lots, distribution and details
- Product
- Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
- Lots / codes
- Lot: 0522J23493, expires: 03/2027.
- Distribution
- Nationwide
- Quantity
- 74,544 bottles
- Recall started
- December 16, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0255-2026
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Class II Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Lots, distribution and details
- Lots / codes
- Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
- Distribution
- Nationwide
- Quantity
- 287,988 Bottles.
- Recall started
- December 16, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0254-2026
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Class II Ongoing
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 250520P4, Exp. Date 05/27
- Distribution
- AZ only
- Quantity
- 1,458 containers
- Recall started
- December 8, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0253-2026
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Class II Ongoing
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 250505P9, Exp. Date 05/27
- Distribution
- AZ only
- Quantity
- 570 bottles
- Recall started
- December 8, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0252-2026
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Class II Ongoing
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.
Reason: Presence of particulate matter – Glass like particles.
Lots, distribution and details
- Product
- Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.
- Lots / codes
- Lot: 25JAN033A, 25JAN033B, Expires: 02/12/2026.
- Distribution
- U.S Nationwide
- Quantity
- 314 boxes of 6,280 pre-filled syringes
- Recall started
- December 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0251-2026
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Class II Ongoing
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Reason: Presence of particulate matter – Glass like particles.
Lots, distribution and details
- Product
- Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
- Lots / codes
- Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
- Distribution
- U.S Nationwide
- Quantity
- 596 boxes of 11,920 pre-filled syringes
- Recall started
- December 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0250-2026
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Class II Ongoing
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Reason: Presence of particulate matter – Glass like particles.
Lots, distribution and details
- Product
- Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
- Lots / codes
- Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026
- Distribution
- U.S Nationwide
- Quantity
- 778 boxes of 15,540 pre-filled syringes
- Recall started
- December 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0249-2026
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Class III Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, N…
Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Lots, distribution and details
- Product
- Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
- Lots / codes
- Lot# 2405003360, Exp Date: Jan 31, 2026
- Distribution
- US Nationwide and PR.
- Quantity
- —
- Recall started
- December 16, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0248-2026
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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
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157…
Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Lots, distribution and details
- Product
- Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
- Lots / codes
- Lot #: 19251311, Exp Date April 2027
- Distribution
- Nationwide within the United States
- Quantity
- 96,948 packs
- Recall started
- December 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0246-2026
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Class II Ongoing
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC…
Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
Lots, distribution and details
- Product
- Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
- Lots / codes
- Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027
- Distribution
- Nationwide within the United States.
- Quantity
- N/A
- Recall started
- December 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0245-2026
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Class II Ongoing
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, N…
Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
Lots, distribution and details
- Product
- Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14
- Lots / codes
- Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026
- Distribution
- Nationwide within the United States.
- Quantity
- N/A
- Recall started
- December 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0244-2026
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Class II Ongoing
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
Reason: Lack of Assurance of Sterlity
Lots, distribution and details
- Lots / codes
- Lot #: 5086623, Exp. Date 03/31/2028
- Distribution
- Nationwide within the United States
- Quantity
- 106,400 units
- Recall started
- December 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0243-2026
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.