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
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
- Lots / codes
- Lot #: AC-016606, Exp. Date 05/06/2023; AC-016636, Exp. Date 07/09/2023; AC-016643, Exp. Date 07/31/2023
- Distribution
- Missouri only
- Quantity
- 2265 syringes
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0632-2023
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Class II Ongoing
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748…
Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Product
- Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
- Lots / codes
- Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;
- Distribution
- Product was distrituded to three direct account in PA.
- Quantity
- 29 x 30-count card, 1 x 100 UD box
- Recall started
- May 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0578-2023
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Class II Ongoing
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Product
- Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
- Lots / codes
- Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024
- Distribution
- Product was distrituded to three direct account in PA.
- Quantity
- 12 5mL bottles
- Recall started
- May 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0577-2023
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Class II Ongoing
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Reason: Lack of Assurance of Sterility: Malformed crimped collar seal
Lots, distribution and details
- Lots / codes
- Lot # 3F497B, EXP 12-31-2025
- Distribution
- Nationwide in the USA
- Quantity
- 51,325 vials
- Recall started
- April 11, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0575-2023
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Class I Ongoing
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad – 500 055, India,…
Reason: Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Lots, distribution and details
- Product
- Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad – 500 055, India, NDC# 31722-629-21.
- Lots / codes
- Lot# E220182, Exp. 12/31/2023
- Distribution
- Nationwide in the USA
- Quantity
- 1568 bottles
- Recall started
- March 13, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0567-2023
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Class I Ongoing
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot/Item#: OMS760-B, Exp: 12/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 140 blister packs
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0573-2023
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Class I Ongoing
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Lots / codes
- Lot#: RO 927996, Exp: 12/25/2024
- Distribution
- Nationwide in the USA.
- Quantity
- 18 blister cards
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0572-2023
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Class I Ongoing
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Product
- Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
- Lots / codes
- No lot number, Exp: 06/2026
- Distribution
- Nationwide in the USA.
- Quantity
- 628 blister cards
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0571-2023
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Class II Ongoing
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKUs a) 0999841; b) 0916071 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0566-2023
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Class II Ongoing
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Product
- Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
- Lots / codes
- SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0565-2023
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Class II Ongoing
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKU 0901839 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0564-2023
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Class II Ongoing
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending.
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0563-2023
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Class II Ongoing
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
Reason: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Lots, distribution and details
- Lots / codes
- Lot: 220888, Exp. 05/20/2023
- Distribution
- FL, GA, TX
- Quantity
- 2880 containers
- Recall started
- April 19, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0562-2023
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Class III Ongoing
Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories…
Reason: Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Lots, distribution and details
- Product
- Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA
- Lots / codes
- Lot: 204603, Exp: 09/30/2024; Lots:208608, 208749, 208445, 209101, 208609, 208295, 209106, 209102, 209212, 208975, 209211, 209706, 209779, 209624, 209839, 209548, Exp: 12/31/2024; Lots: 204604, 204601, 204550, 204599, 204871, 204555, 205616, Exp: 11/30/2024; Lots: 205612, 204832, 205127, 204996, 205615, 205324, 205494, 205611, 206232, Exp: 10/31/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 403 boxes
- Recall started
- April 20, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0556-2023
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Class II Ongoing
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52
- Lots / codes
- Lot #: F114302001, Exp. Date 05/31/2023
- Distribution
- Nationwide with the United States
- Quantity
- 23 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0554-2023
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Class II Ongoing
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
- Distribution
- Nationwide with the United States
- Quantity
- a)164 bottles; b) 198 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0553-2023
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Class II Ongoing
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- a) Lot #: F105692201, Exp. Date 09/30/2024; F105692203, Exp. Date 02/28/2025 b) Lot #: F105692202, Exp. Date 02/28/2025
- Distribution
- Nationwide with the United States
- Quantity
- a) 198 bottles; b) 22 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0552-2023
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Class II Ongoing
Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- a) Lot #: F106252201, Exp. Date 09/30/2024; F106252301, F106252303, Exp. Date 5/31/2025; F106252304, Exp. Date 07/31/2025 b) Lot #: F106252302, Exp. Date 07/31/2025
- Distribution
- Nationwide with the United States
- Quantity
- a) 230 bottles; b) 22 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0551-2023
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Class II Ongoing
Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52
- Lots / codes
- Lot#: F107752201, Exp. Date 05/31/2024
- Distribution
- Nationwide with the United States
- Quantity
- 33 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0550-2023
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Class II Ongoing
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
Reason: CGMP Deviations
Lots, distribution and details
- Product
- BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
- Lots / codes
- Lot#: F117312201, Exp. Date 06/30/2024
- Distribution
- Nationwide with the United States
- Quantity
- 6 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0549-2023
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Class II Ongoing
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
- Lots / codes
- Lot # F117192201, Exp. Date 4/30/2023
- Distribution
- Nationwide with the United States
- Quantity
- 99 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0548-2023
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Class II Ongoing
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Reason: Marketed Without an Approved NDA/ANDA
Lots, distribution and details
- Product
- CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
- Lots / codes
- All lots
- Distribution
- Nationwide within the United States
- Quantity
- 2000 inhalers
- Recall started
- April 1, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0541-2023
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Class II Ongoing
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Reason: Out of specification (OOS) for Spectroscopic Identification test by IR.
Lots, distribution and details
- Product
- Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
- Lots / codes
- Lot #22143120, Exp. Date: June 2024
- Distribution
- Nationwide in the USA
- Quantity
- 135 bottles
- Recall started
- March 17, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0539-2023
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Class II Ongoing
C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
Reason: Lack of assurance of sterility.
Lots, distribution and details
- Product
- C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
- Lots / codes
- Lot #: 73810, Exp. Date 5/1/2023
- Distribution
- MS only
- Quantity
- 45 vials
- Recall started
- April 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0538-2023
-
Class II Ongoing
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
Reason: CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Lots, distribution and details
- Lots / codes
- Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
- Distribution
- Nationwide in the USA
- Quantity
- 69,615 bottles
- Recall started
- April 6, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0537-2023
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 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.