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.
1,094 recalls
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Class I Ongoing
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Cons…
Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Lots, distribution and details
- Product
- SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
- Lots / codes
- Lot# 024122661Al, Exp Date 12/2027
- Distribution
- Nationwide in the US.
- Quantity
- unknown
- Recall started
- January 28, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0300-2025
-
Class I Ongoing
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each,…
Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Lots, distribution and details
- Product
- SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1
- Lots / codes
- Lot# 024122661Al, Exp Date 12/2027
- Distribution
- Nationwide in the US.
- Quantity
- 4,176 cartons
- Recall started
- January 28, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0299-2025
-
Class II Completed
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02
Reason: Presence of foreign substance: Presence of Benzene.
Lots, distribution and details
- Lots / codes
- Lot #: 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26.
- Distribution
- Nationwide in the U.S
- Quantity
- 244,412 Cartons; 30 sachets /Carton
- Recall started
- March 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0294-2025
-
Class II Completed
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
Reason: Presence of foreign substance: Presence of Benzene.
Lots, distribution and details
- Product
- Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
- Lots / codes
- Lot #: 5501127A, 5501236A, Exp Apr-25; 5501341A, Exp Jun-25; 5501406A, Exp Jul-25; 5501408A, Exp Aug-25; 5501516A, Exp Sep-25; 5501568A, Exp Oct-25; 5501829A, Exp Mar-26; 5502000A, Exp Jul-26; 5502004A, 5502005A, Exp Aug-26; 5502092A, Exp Oct-26; 5502217A, Exp Dec-26; 5502262A, Exp Jan-27
- Distribution
- Nationwide in the U.S
- Quantity
- 195,952 Cartons; 30 sachets/Carton.
- Recall started
- March 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0293-2025
-
Class II Ongoing
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Reason: Chemical contamination: presence of benzene
Lots, distribution and details
- Lots / codes
- Lot #: 4970743A, Exp 3/31/2026; 9712793A, Exp9/30/2026; 8363513B, Exp 12/31/2026; 1391304A, 5101574A, Exp 5/31/2027; 1292084A, 1292084B, 1292084C, Exp 7/31/2027; 2892384A, Exp 8/31/2027; 6203044A, 6203044B, Exp 10/31/2027; 2153564A, 2153564B, Exp 12/31/2027; 2163564A, Exp 1/31/2028
- Distribution
- USA Nationwide
- Quantity
- 112045 tubes
- Recall started
- March 11, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0284-2025
-
Class II Ongoing
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Reason: Chemical contamination: presence of benzene
Lots, distribution and details
- Lots / codes
- Lot #: 4970743B, 4970743C Exp 3/31/2026, 9722793A, Exp 9/30/2026; 8363513A, Exp 12/3/2026; 2822284A, Exp 8/31/2027; 2143554A, Exp 12/31/2027.
- Distribution
- USA Nationwide
- Quantity
- 100,970 tubes
- Recall started
- March 11, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0283-2025
-
Class II Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Lots, distribution and details
- Lots / codes
- Lot: 084A067, Exp 12/31/2025
- Distribution
- Nationwide in the U.S
- Quantity
- 90960 bottles
- Recall started
- March 11, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0282-2025
-
Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Lots, distribution and details
- Lots / codes
- Lot #: DTB23111A, Exp 8/31/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 1223 bottles
- Recall started
- March 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0277-2025
-
Class II Ongoing
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
Reason: Chemical Contamination: Presence of benzene
Lots, distribution and details
- Lots / codes
- Lot#: 23-09328, Exp.: 09/2025
- Distribution
- Nationwide in the U.S.A
- Quantity
- 13,440 tubes
- Recall started
- February 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0274-2025
-
Class II Ongoing
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Reason: Chemical Contamination: Presence of benzene.
Lots, distribution and details
- Lots / codes
- Lot #: 9762, Exp. Date 2/28/2025; 9763, 9764, 9765, Exp. Date 3/31/2025; 9869, 9870, Exp. Date 5/31/2025; 9871, 9872, Exp. Date 7/31/2025; 9996, 9997, 9998, Exp. Date 8/31/2025; 9995, Exp. Date 10/31/2025; 0154, 0153, 0326, Exp. Date 1/31/2026; 0155, 0156, 0161, 0327, 0329, 0328, Exp. Date 2/28/2026; 0479, 0480, Exp. Date 5/31/2026.
- Distribution
- Nationwide within the USA
- Quantity
- 642,131 tubes
- Recall started
- February 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0273-2025
-
Class II Ongoing
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Di…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Lots / codes
- Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026.
- Distribution
- USA Nationwide
- Quantity
- 1,893 vials
- Recall started
- February 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0256-2025
-
Class II Ongoing
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Di…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Lots / codes
- Lot: a) P300072, P300073 Exp. Feb-2025; P300153, Exp. Jun-25; P300195, Exp. Aug-2025; P400014, P400017, Exp. Dec-2025; P400070, Exp. Feb-2026; P400112, May-2026; P400142, Exp. Jul-2026; b) P300068, Exp. Feb-2025; P300154, Exp.Jun-2025; P400015, P400018, Exp. Dec-2025; P400068, Exp. Feb-2026; P400114, Exp. May-2026; P400139, Exp.Jul-2026.
- Distribution
- USA Nationwide
- Quantity
- 36,978 vials
- Recall started
- February 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0255-2025
-
Class II Ongoing
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
- Lots / codes
- Lot #: AD16615, Exp. Date 07/2025
- Distribution
- Nationwide within in the USA.
- Quantity
- 9840 bottles
- Recall started
- February 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0249-2025
-
Class I Ongoing
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA…
Reason: Defective delivery system – patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Lots, distribution and details
- Product
- Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
- Lots / codes
- Lot #: 108319, Exp: 04/30/2027
- Distribution
- USA Nationwide
- Quantity
- 112,128 cartons (5 pouches/carton)
- Recall started
- January 31, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0245-2025
-
Class II Ongoing
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major…
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lots, distribution and details
- Product
- Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
- Lots / codes
- Lot #s: N01422, N01423, Exp 03/31/2025; N01661, N01662, Exp 09/30/2025; N01746, N01750, Exp 10/31/2025; N01876, N01877, Exp 03/31/2026; N01899, N01900, N01975, Exp 04/30/2026.
- Distribution
- Nationwide U.S. and Puerto rico
- Quantity
- 27,525 cartons
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0228-2025
-
Class II Ongoing
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major…
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lots, distribution and details
- Product
- Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
- Lots / codes
- Lot #s: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, Exp 08/31/2026.
- Distribution
- Nationwide U.S. and Puerto rico
- Quantity
- 94,349 cartons
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0227-2025
-
Class II Ongoing
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Maj…
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lots, distribution and details
- Product
- Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
- Lots / codes
- Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026.
- Distribution
- Nationwide U.S. and Puerto rico
- Quantity
- 82,281 cartons
- Recall started
- January 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0226-2025
-
Class I Ongoing
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Reason: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- USA nationwide.
- Quantity
- 44,397 amber glass vials
- Recall started
- December 20, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0223-2025
-
Class II Ongoing
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ…
Reason: Failed Dissolution Specifications.
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
- Lots / codes
- Lot# T05224; Exp. 02/2026
- Distribution
- Nationwide in the USA
- Quantity
- 6997 cartons
- Recall started
- January 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0221-2025
-
Class II Ongoing
HydrALAZINE Hydrochloride, 100 Tablets (10×10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-32…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- HydrALAZINE Hydrochloride, 100 Tablets (10×10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
- Lots / codes
- Lot #: 0000127410, 63739-328-10, Exp. Date 30-Apr-2025; 0000127579, Exp. Date 31-Aug-2025; 0000128245, Exp. Date 31-Dec-2025; 0000128486, Exp. Date 28-Feb-2026.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- January 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0220-2025
-
Class II Ongoing
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10×10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. N…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10×10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
- Lots / codes
- Lot #: 0000127312, Exp. Date 31-Mar-2025; 0000127576, 0000127577, Exp. Date 31-Jul-2025; 0000128204, Exp. Date 31-Dec-2025; 0000128358, Exp. Date 31-Jan-2026
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- January 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0219-2025
-
Class II Ongoing
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC…
Reason: Failed Stability Specifications – 12-month stability test result for one of the known peptides is below the specification limit
Lots, distribution and details
- Product
- Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
- Lots / codes
- Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
- Distribution
- Product was distributed nationwide.
- Quantity
- 34,636 cartons
- Recall started
- January 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0218-2025
-
Class II Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lots, distribution and details
- Lots / codes
- Lot#: 083J033, Exp. Date 09/2025
- Distribution
- Distributed to one (1) Us Distributor in NJ
- Quantity
- 118104 bottles
- Recall started
- January 23, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0214-2025
-
Class II Ongoing
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Lots, distribution and details
- Lots / codes
- Lot# 04647349, Exp Date 5/31/2029
- Distribution
- Nationwide USA
- Quantity
- 192 vials
- Recall started
- January 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0213-2025
-
Class II Terminated
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3×10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10×10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major…
Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3×10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10×10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
- Lots / codes
- Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
- Distribution
- Nationwide within the United States
- Quantity
- a) 6408 boxes and b)1488 boxes
- Recall started
- January 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0212-2025
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.