Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
3,222 recalls
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Class II Ongoing
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- 30
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0040-2026
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Class II Ongoing
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- 235
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0039-2026
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Class II Ongoing
Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- 17
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0038-2026
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Class II Ongoing
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Reason: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Lots, distribution and details
- Lots / codes
- Lot #: P24ZLK1, Exp 5/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 4,680 500-count bottles
- Recall started
- September 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0014-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
- Lots / codes
- Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
- Distribution
- Nationwide
- Quantity
- 1394 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0013-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
- Lots / codes
- Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
- Distribution
- Nationwide
- Quantity
- 866 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0012-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
- Lots / codes
- Lots N02009 & N02026, exp. date 02/28/2026
- Distribution
- Nationwide
- Quantity
- 506 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0011-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)003090471306…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
- Lots / codes
- Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
- Distribution
- Nationwide
- Quantity
- 1256 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0010-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Lots / codes
- Lots N01943 and Lot N02025, exp. date 02/28/2026
- Distribution
- Nationwide
- Quantity
- 2064 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0009-2026
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Class II Ongoing
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598…
Reason: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Lots, distribution and details
- Product
- Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
- Lots / codes
- Lot # K250048
- Distribution
- Nationwide within the USA.
- Quantity
- 571 vials
- Recall started
- September 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0008-2026
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Class II Ongoing
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3×28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC:…
Reason: Failed Content Uniformity Specifications
Lots, distribution and details
- Product
- Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3×28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28
- Lots / codes
- Lot # LF41138A; Exp 06/30/2027
- Distribution
- U.S. Nationwide
- Quantity
- 2192 cartons
- Recall started
- September 2, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0007-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehra…
Reason: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
- Lots / codes
- Lot # D2300045, Exp 12/31/2025.
- Distribution
- Nationwide in the US
- Quantity
- 54,432 bottles
- Recall started
- September 16, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0006-2026
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Class II Ongoing
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4×1 Gallon Case, 5 Gallon Pail, 55 G…
Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Lots, distribution and details
- Product
- AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4×1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.
- Lots / codes
- Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- September 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0005-2026
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Class II Ongoing
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000m…
Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Lots, distribution and details
- Product
- Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4×1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.
- Lots / codes
- Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- September 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0004-2026
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Class II Terminated
Bevacizumab 1.75 mg/0.07 mL – 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
Reason: Lack of assurance of sterility.
Lots, distribution and details
- Lots / codes
- Lot # 20250708-768A26, BUD: Oct 06, 2025 20250715-944DF2 BUD: Oct 13, 2025 20250722-55C603 BUD: Oct 20, 2025 20250722-5DC113 BUD: Oct 20, 2025
- Distribution
- Nationwide in the US
- Quantity
- 2,669 syringes
- Recall started
- September 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0003-2026
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Class II Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lots, distribution and details
- Lots / codes
- Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
- Distribution
- Nationwide in the US
- Quantity
- 493,468 bottles
- Recall started
- September 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0677-2025
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Class II Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston,…
Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lots, distribution and details
- Product
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
- Lots / codes
- a) lot # VE0614 exp. date 12/2025 UPC:(01)00360505058914 (5 mL) b) lot # VE0616 exp. date 12/2025 UPC:(01)0(03)60505058921 (10 mL)
- Distribution
- Nationwide in the US
- Quantity
- 151,034 bottles
- Recall started
- September 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0676-2025
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Class II Ongoing
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3×10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
Reason: Failed Dissolution Specifications.
Lots, distribution and details
- Product
- Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3×10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
- Lots / codes
- Lot #: 1024078, Exp. Date 08/31/2026
- Distribution
- Nationwide in the USA.
- Quantity
- 360 cartons
- Recall started
- September 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0675-2025
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Class II Ongoing
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots, distribution and details
- Lots / codes
- Lot#: E409309, Exp 12/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 600 30-count bottles
- Recall started
- September 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0002-2026
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Class II Ongoing
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots, distribution and details
- Lots / codes
- Lot#: E409308, Exp 12/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 912 30-count bottles
- Recall started
- September 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0001-2026
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Class III Ongoing
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
Reason: Subpotent drug
Lots, distribution and details
- Lots / codes
- Lot # 24EJA180, Exp 06/01/2027
- Distribution
- Nationwide in the USA
- Quantity
- 2,680 bottles
- Recall started
- August 19, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0674-2025
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Class III Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx…
Reason: Failed Impurities/Degradation Specifications:
Lots, distribution and details
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
- Lots / codes
- Lot#: GPC250181A, Exp Date: 06-19-2027
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 11,928 bottles
- Recall started
- August 28, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0673-2025
-
Class III Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx…
Reason: Failed Impurities/Degradation Specifications:
Lots, distribution and details
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
- Lots / codes
- Lot#: GPC250179A, Exp Date: 06-22-2027
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 11,909 bottles
- Recall started
- August 28, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0672-2025
-
Class III Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx…
Reason: Failed Impurities/Degradation Specifications:
Lots, distribution and details
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
- Lots / codes
- Lot#: GPC250178A, Exp Date: 06-22-2027
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 9,917 bottles
- Recall started
- August 28, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0671-2025
-
Class III Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx…
Reason: Failed Impurities/Degradation Specifications:
Lots, distribution and details
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
- Lots / codes
- lot#: GPC250159A, Exp Date: 06-22-2027
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 11,895 bottles
- Recall started
- August 28, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0670-2025
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 2, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.