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
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, T…
Reason: Presence of particulate matter: potential presence of metal particulates in the product.
Lots, distribution and details
- Product
- Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.
- Lots / codes
- Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
- Distribution
- Nationwide in the USA
- Quantity
- 845 kits
- Recall started
- December 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0242-2026
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Class II Ongoing
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland…
Reason: Presence of particulate matter: potential presence of metal particulates in the product.
Lots, distribution and details
- Product
- Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03
- Lots / codes
- Lot #: Z014503, Exp 11/15/2027
- Distribution
- Nationwide in the USA
- Quantity
- 3 – single dose kits
- Recall started
- December 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0241-2026
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Class II Ongoing
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
Reason: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Lots, distribution and details
- Lots / codes
- Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
- Distribution
- Nationwide within the United States
- Quantity
- 17,664 units
- Recall started
- December 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0240-2026
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Class II Ongoing
Ondansetron ODT Tablets, USP 4mg, 1×10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
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 ODT Tablets, USP 4mg, 1×10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
- Lots / codes
- Lot: J1325J, I1725P, EXP Date: 4/30/2027.
- Distribution
- Natinowide in the USA
- Quantity
- 575 1×10 Foil Blister Packs
- Recall started
- November 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0239-2026
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Class III Ongoing
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial,…
Reason: Subpotent product:out of specification assay results observed during long term stability testing.
Lots, distribution and details
- Product
- Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
- Lots / codes
- Lot#: A250043, EXP Date 06/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 71,310 10mL vials
- 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-0238-2026
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Class III Ongoing
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70…
Reason: Subpotent product:out of specification assay results observed during long term stability testing.
Lots, distribution and details
- Product
- Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
- Lots / codes
- Lot #: A250020, Exp Date 06/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 28,660 20mL vials
- 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-0237-2026
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Class III Ongoing
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 700…
Reason: Subpotent product:out of specification assay results observed during long term stability testing.
Lots, distribution and details
- Product
- Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10×5 mL single dose vial per Carton NDC 70069-141-10.
- Lots / codes
- Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
- Distribution
- Nationwide in the USA
- Quantity
- 52,340 5mL vials
- 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-0236-2026
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Class II Ongoing
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot GS065762
- Distribution
- Nationwide within the USA
- Quantity
- 2472 HDPE Bottles
- Recall started
- November 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0235-2026
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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
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 03…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.
- Lots / codes
- Lot: D05159I, expires: 07-31-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 40 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-0233-2026
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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 II Ongoing
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmac…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.
- Lots / codes
- Lot: D05159G, expires: 07-31-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 5,520 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-0231-2026
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Class II Ongoing
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, Yor…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
- Lots / codes
- Lot: D05159C, expires: 07-31-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 5,825
- 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-0230-2026
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Class II Ongoing
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.
- Lots / codes
- Lot: D05362A, expires: 07-31-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 12,033 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-0229-2026
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Class II Ongoing
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, Yor…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
- Lots / codes
- Lot: D05337B, expires: 06-30-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 18,789 cartons- 50 cartridges /carton
- 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-0228-2026
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Class II Ongoing
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Reason: Defective container – seal not adhering to bottles
Lots, distribution and details
- Lots / codes
- Lot # QB00865, exp. date Feb 2028
- Distribution
- Nationwide.
- Quantity
- 52,128 bottles
- Recall started
- November 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0227-2026
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Class II Ongoing
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots, distribution and details
- Product
- Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
- Lots / codes
- Lot 5PB0183, exp 1/31/2027
- Distribution
- Nationwide in the US
- Quantity
- 12,576 bottles
- Recall started
- November 14, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0226-2026
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Class II Ongoing
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots, distribution and details
- Product
- Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
- Lots / codes
- Lot 5PB0164, exp 1/31/2027
- Distribution
- Nationwide in the US
- Quantity
- 15,744 bottles
- Recall started
- November 14, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0225-2026
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Class II Ongoing
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots, distribution and details
- Lots / codes
- Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
- Distribution
- Nationwide in the US
- Quantity
- 63,504 bottles
- Recall started
- November 14, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0224-2026
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Class III Ongoing
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Lots, distribution and details
- Product
- Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
- Lots / codes
- Lot 1312405; Exp 09/28/2027
- Distribution
- U.S. Nationwide
- Quantity
- 3,528 30 mL Bottles
- 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-0223-2026
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Class III Ongoing
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Reason: Cross Contamination with Other Products
Lots, distribution and details
- Lots / codes
- Lot# 17240988; Exp. 05/31/2026
- Distribution
- U.S. Nationwide
- Quantity
- 672 90-count bottles
- Recall started
- November 18, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0222-2026
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Class II Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichit…
Reason: Incorrect Product Formulation
Lots, distribution and details
- Product
- Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
- Lots / codes
- Lot#: C274-000047958; Exp. December 19, 2025
- Distribution
- U.S. Nationwide.
- Quantity
- 2980 syringes
- Recall started
- November 20, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0221-2026
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Class II Ongoing
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin…
Reason: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Lots, distribution and details
- Product
- Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur – 441108, INDIA, NDC 70748-274-01
- Lots / codes
- Lot #: WB00006, Exp 12/31/2026
- Distribution
- FL, MA, MI & OH
- Quantity
- 32736 vials
- Recall started
- November 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0220-2026
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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
Lanthanum Carbonate chewable tablets, 1000mg*, 10×9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharm…
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., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
- Lots / codes
- Lot# NB240314, exp 12/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- N/A
- 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-0218-2026
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.