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
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 6004…
Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lots, distribution and details
- Product
- Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
- Lots / codes
- Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
- Distribution
- US Nationwide and Puerto Rico.
- Quantity
- 220,400 cartridges
- Recall started
- May 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0565-2024
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Class II Ongoing
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045…
Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lots, distribution and details
- Product
- Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03
- Lots / codes
- Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10
- Distribution
- US Nationwide and Puerto Rico.
- Quantity
- 84,710 cartridges
- Recall started
- May 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0564-2024
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Class II Completed
Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
Reason: Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Lots, distribution and details
- Lots / codes
- Product lot: 240312JL-629220; Exp. 09/08/2024
- Distribution
- U.S. Nationwide
- Quantity
- 9896 tablets
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0563-2024
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Class II Terminated
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 0792…
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
- Lots / codes
- Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 165,678, 90-count bottles
- Recall started
- May 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0562-2024
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Class II Ongoing
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc.…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
- Lots / codes
- Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024
- Distribution
- Nationwide within the United States
- Quantity
- 34,448 bottles
- Recall started
- June 4, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0561-2024
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Class II Terminated
Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands – Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0…
Reason: Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Lots, distribution and details
- Product
- Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands – Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0
- Lots / codes
- Rite Aid – lot # 0607983, expiration date: 07/2026, NDC # 11822-3135-2 Kroger- lot # 0607983, expiration date: 07/2026, NDC# 30142-069-27 Harris Teeter – lot # 0607983, expiration date: 07/2026, NDC# 72036-069-27 CVS- lot # 0607983, expiration date: 07/2026, NDC # 59779-069-27
- Distribution
- Nationwide.
- Quantity
- 1015 cases
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0560-2024
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Class II Terminated
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC…
Reason: Failed Content Uniformity Specifications
Lots, distribution and details
- Product
- Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03
- Lots / codes
- Lot F201519, Expiry: November 2024
- Distribution
- Nationwide in the US
- Quantity
- 3,552 bottles
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0559-2024
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Class II Ongoing
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Lots, distribution and details
- Lots / codes
- Lot Number: H29585, No Expiration date
- Distribution
- US Nationwide
- Quantity
- 20 bottles
- Recall started
- May 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0558-2024
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Class II Terminated
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Reason: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Lots, distribution and details
- Lots / codes
- Lot #: 0855, Exp. 8/31/ 2025
- Distribution
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
- Quantity
- 113,544 bottles
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0557-2024
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Class III Ongoing
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
Reason: Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Lots, distribution and details
- Lots / codes
- Lot #: 3EF22003, Exp 6/30/2025
- Distribution
- USA nationwide.
- Quantity
- 15,500 single dose vials
- Recall started
- May 22, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0556-2024
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Class II Ongoing
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150…
Reason: Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Lots, distribution and details
- Product
- Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30
- Lots / codes
- Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
- Distribution
- USA Nationwide
- Quantity
- 70,125 vials
- Recall started
- May 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0555-2024
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Class I Ongoing
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Reason: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Lots, distribution and details
- Lots / codes
- Lot #: F1030001, Exp. Date 12/31/2024
- Distribution
- Nationwide within the USA.
- Quantity
- 2806 vials
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0554-2024
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Class I Ongoing
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Reason: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Lots, distribution and details
- Lots / codes
- Lot #: F1040001, Exp. Date 12/31/2024
- Distribution
- Nationwide within the USA.
- Quantity
- 762 vials
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0553-2024
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Class III Ongoing
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04
Reason: Defective Container
Lots, distribution and details
- Lots / codes
- Lot #: Y000085, Exp 4/25/2025
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0552-2024
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Class III Ongoing
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03
Reason: Defective Container
Lots, distribution and details
- Lots / codes
- Lot #: X024051, Exp 04/25/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2,551 units
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0551-2024
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Class III Ongoing
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
Reason: Defective Container
Lots, distribution and details
- Lots / codes
- Lot #: X025346, Exp 3/3/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2,886 units
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0550-2024
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Class II Terminated
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
Reason: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Lots, distribution and details
- Lots / codes
- Lot # B2906961-042524, exp. date 02/26/2027
- Distribution
- Product was distributed to one medical facility.
- Quantity
- 8 bottles
- Recall started
- May 31, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0549-2024
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Class II Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: 23NOV018 Exp. 6/17/24
- Distribution
- US Nationwide
- Quantity
- 4,280 boxes
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0548-2024
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Class II Ongoing
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledg…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
- Lots / codes
- Lot:23APR005 Exp. 5/1/2024 Lot:23MAY024 Exp. 5/15/2024 Lot:23JUN010 Exp. 5/30/2024 Lot:23JUN016 Exp. 6/7/2024 Lot:23JUN047 Exp. 7/4/2024 Lot:23JUL013 Exp. 7/11/2024 Lot:23JUL029 Exp. 7/25/2024 Lot:23JUL030 Exp. 8/1/2024 Lot:23AUG016 Exp. 8/7/2024 Lot:23AUG042 Exp. 9/27/2024 Lot:23SEP017 Exp. 7/13/2024 Lot:23OCT039 Exp. 8/3/2024 Lot:23NOV022 Exp. 8/24/2024 Lot:23NOV036 Exp. 8/29/2024 Lot:23DEC021 Exp. 10/4/2024 Lot:24JAN018 Exp. 10/11/2024 Lot:24JAN026 Exp. 10/24/2024 Lot:24JAN040 Exp. 11/2/2024 Lot:24FEB021 Exp. 11/16/2024 Lot:24MAR005 Exp. 12/12/2024
- Distribution
- US Nationwide
- Quantity
- 136,005 units
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0547-2024
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Class II Ongoing
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Lab…
Reason: Failed Stability Specifications – at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Lots, distribution and details
- Product
- Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01.
- Lots / codes
- Lot: 082657 (kit 23-9004), Exp: July 2024.
- Distribution
- U.S. Nationwide.
- Quantity
- 43,768 kits
- Recall started
- May 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0546-2024
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Class II Completed
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
Reason: Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Lots, distribution and details
- Lots / codes
- Lot#: 1142404 Exp. Date 02/27/2027
- Distribution
- Nationwide within the United States
- Quantity
- 473 cases (5676 Bottles)
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0545-2024
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Class III Terminated
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham…
Reason: Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Lots, distribution and details
- Product
- Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37
- Lots / codes
- Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
- Distribution
- Nationwide within the United States
- Quantity
- 463 Cartons
- Recall started
- May 17, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0544-2024
-
Class III Ongoing
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
- Lots / codes
- Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
- Distribution
- Nationwide within the United States
- Quantity
- 13,440 units
- Recall started
- May 16, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0543-2024
-
Class III Ongoing
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
- Lots / codes
- Lot #: M310493, Exp. Date 01/2025; M308397, Exp. Date 11/2024; M305337, Exp. Date 10/2024; M400155, Exp. Date 06/2025; M314660, Exp. Date 05/2025
- Distribution
- Nationwide within the United States
- Quantity
- 21,360 units
- Recall started
- May 16, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0542-2024
-
Class III Ongoing
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
Reason: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Lots, distribution and details
- Lots / codes
- Lot: 23132611, Exp 07/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- N/A
- Recall started
- May 16, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0541-2024
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 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.