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 I Terminated
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Reason: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Lots, distribution and details
- Lots / codes
- Lot# 2114228, EXP. 02/29/2024
- Distribution
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Quantity
- 192 bottles
- Recall started
- November 6, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0145-2024
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Class II Terminated
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad…
Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
- Lots / codes
- Lot # a) GS036488, GS037091, GS037701, Exp. 08/31/2024; b) GS037090, GS037702, Exp. 08/31/2024; c) GS036677, GS037117, GS037699, Exp. 08/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 5626 bottles
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0130-2024
-
Class II Terminated
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorpor…
Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
- Lots / codes
- Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;
- Distribution
- Nationwide in the USA
- Quantity
- 2502 bottles
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0129-2024
-
Class II Terminated
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad…
Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
- Lots / codes
- Lot # a) Lot GS041383, GS042141, Exp. 08/31/2024; b) Lot GS040841, Lot GS041384, Lot GS042039, Exp. 08/31/2024; c) Lot GS040910, Lot GS041621, Lot GS042237, Exp. 08/31/2024;
- Distribution
- Nationwide in the USA
- Quantity
- 1941 bottles
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0128-2024
-
Class III Terminated
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Reason: OOS for viscosity
Lots, distribution and details
- Lots / codes
- Lot #: 100029472, Exp. 2/29/2024
- Distribution
- USA nationwide
- Quantity
- —
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0127-2024
-
Class III Terminated
Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08
Reason: Failed Excipient Specifications: high content of ethylene glycol (EG)
Lots, distribution and details
- Lots / codes
- Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
- Distribution
- Nationwide USA
- Quantity
- Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl
- Recall started
- October 17, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0126-2024
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Class III Ongoing
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Us…
Reason: Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Lots, distribution and details
- Product
- Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01
- Lots / codes
- Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
- Distribution
- Nationwide in the USA
- Quantity
- 756 bottles
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0125-2024
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Class II Ongoing
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-1…
Reason: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Lots, distribution and details
- Product
- Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
- Lots / codes
- Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- November 7, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0124-2024
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Class II Ongoing
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 684…
Reason: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Lots, distribution and details
- Product
- Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01
- Lots / codes
- Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484; Exp 8/2025 Lot# 19233490; Exp 8/2025
- Distribution
- Nationwide
- Quantity
- 37,200 bottles
- Recall started
- November 7, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0123-2024
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Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Lots / codes
- Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 4,074
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0122-2024
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Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario,…
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
- Lots / codes
- Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 25,776
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0121-2024
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Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apo…
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
- Lots / codes
- Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 48,623
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0120-2024
-
Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontar…
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
- Lots / codes
- Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 34,392
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0119-2024
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Class I Ongoing
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Product
- LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 8,784 bottles
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0136-2024
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Class I Ongoing
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 11,782 bottles
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0135-2024
-
Class I Ongoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton);…
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Product
- LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 28477 cartons
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0134-2024
-
Class I Ongoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 119,871 bottles
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0133-2024
-
Class I Ongoing
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 21,802 bottles
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0132-2024
-
Class I Ongoing
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in In…
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lots, distribution and details
- Product
- LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
- Lots / codes
- ALL LOTS
- Distribution
- Nationwide in the USA
- Quantity
- 11629 units
- Recall started
- October 31, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0131-2024
-
Class I Ongoing
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10×10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28…
Reason: Presence of Particulate Matter: Silicone
Lots, distribution and details
- Product
- ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10×10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).
- Lots / codes
- Lot # 10000798, Expiration Date 03/31/2025
- Distribution
- Nationwide
- Quantity
- 38,200 vials
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0118-2024
-
Class I Ongoing
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela P…
Reason: Presence of Particulate Matter: Silicone
Lots, distribution and details
- Product
- Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).
- Lots / codes
- Lot # 10001088 exp 07/31/2024
- Distribution
- Nationwide
- Quantity
- 23,425 vials
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0117-2024
-
Class I Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-50…
Reason: Presence of Particulate Matter: Silicone
Lots, distribution and details
- Product
- 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20×50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
- Lots / codes
- a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024
- Distribution
- Nationwide
- Quantity
- 355,220 vials
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0116-2024
-
Class II Terminated
Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)
Reason: Failed Viscosity Specifications: Out-of-specification test results for viscosity
Lots, distribution and details
- Lots / codes
- LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
- Distribution
- Distributed to one distributor in TN who may have further distributed.
- Quantity
- 1,792 bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0115-2024
-
Class III Terminated
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
Reason: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Lots, distribution and details
- Lots / codes
- Lot#: a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024
- Distribution
- Nationwide USA
- Quantity
- 12 cards
- Recall started
- October 27, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0114-2024
-
Class III Terminated
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
Reason: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Lots, distribution and details
- Lots / codes
- Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
- Distribution
- Nationwide USA
- Quantity
- 1,344 cards
- Recall started
- October 27, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0113-2024
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 4, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.