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
-
Class III Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 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), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
- Lots / codes
- Lot#: GPC250158A, Exp Date: 06-22-2027
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 3,384 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-0669-2025
-
Class II Ongoing
edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Lots, distribution and details
- Lots / codes
- Lot # 58170A and 58172A, Exp Date: 09/2025
- Distribution
- CA, GA only
- Quantity
- N/A
- 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-0668-2025
-
Class II Ongoing
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825.
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Lots, distribution and details
- Lots / codes
- Lot # 58170A and 58172A, Exp Date: 09/2025
- Distribution
- CA, GA only
- Quantity
- N/A
- 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-0667-2025
-
Class II Ongoing
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Lots, distribution and details
- Lots / codes
- Lot # 58170A and 58172A, Exp Date: 09/2025
- Distribution
- CA, GA only
- Quantity
- N/A
- 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-0666-2025
-
Class II Ongoing
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Lots, distribution and details
- Lots / codes
- Lot # 58170A and 58172A, Exp Date: 09/2025
- Distribution
- CA, GA only
- Quantity
- N/A
- 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-0665-2025
-
Class II Ongoing
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Lots, distribution and details
- Product
- Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
- Lots / codes
- Lot # 58170A and 58172A, Exp Date: 09/2025
- Distribution
- CA, GA only
- Quantity
- N/A
- 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-0664-2025
-
Class II Ongoing
ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Lots, distribution and details
- Lots / codes
- Lot # 58170A and 58172A, Exp Date: 09/2025
- Distribution
- CA, GA only
- Quantity
- 125
- 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-0663-2025
-
Class II Ongoing
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,…
Reason: CGMP Deviations: Market complaints received for gritty texture (grainy)
Lots, distribution and details
- Product
- Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
- Lots / codes
- Batch # 19252524, Exp Date: May 2027
- Distribution
- Nationwide within the United States
- Quantity
- 13824 tubes
- Recall started
- September 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0662-2025
-
Class III Ongoing
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
Reason: Cross Contamination with Other Products.
Lots, distribution and details
- Product
- TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
- Lots / codes
- Lot 0662036; Exp Date 06/19/2027
- Distribution
- US Nationwide.
- Quantity
- 60 bottles
- Recall started
- August 25, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0661-2025
-
Class III Ongoing
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
Reason: Cross Contamination with Other Products.
Lots, distribution and details
- Product
- Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
- Lots / codes
- Lot 0662036; Exp. Date 06/19/2027
- Distribution
- US Nationwide.
- Quantity
- 1860 bottles
- Recall started
- August 25, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0660-2025
-
Class II Ongoing
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 20240610, Exp. Date 06/2029
- Distribution
- N/A
- Quantity
- 500 cases
- Recall started
- July 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0659-2025
-
Class II Ongoing
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Reason: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Lots, distribution and details
- Lots / codes
- Lot# AD70995; Exp 10/31/2025
- Distribution
- US Nationwide.
- Quantity
- 1870 kits
- Recall started
- September 3, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0658-2025
-
Class II Ongoing
Entecavir Tablets, USP, 1 mg, 30 Tablets, 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
Lots, distribution and details
- Lots / codes
- Lot E309377, Exp 11/30/2025
- Distribution
- U.S. Nationwide
- Quantity
- 4440 bottles
- Recall started
- September 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0657-2025
-
Class II Ongoing
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, 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
Lots, distribution and details
- Lots / codes
- Lot E309376; Exp 11/30/2025
- Distribution
- U.S. Nationwide
- Quantity
- 4344 bottles
- Recall started
- September 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0656-2025
-
Class I Ongoing
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA),…
Reason: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Lots, distribution and details
- Product
- Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
- Lots / codes
- Lot No: GMML24026A, Expires: 09/30/2027
- Distribution
- Nationwide within the U.S.A
- Quantity
- 230 90-count bottles
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0655-2025
-
Class II Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count…
Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
- Lots / codes
- Lot #: a) F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. b) F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. c) F118062506, Exp. Date 06/30/2027. d) F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, Exp. Date 08/31/2027.
- Distribution
- Nationwide within the United States
- Quantity
- a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
- Recall started
- August 20, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0654-2025
-
Class II Ongoing
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Lots, distribution and details
- Lots / codes
- Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
- Distribution
- U.S. Nationwide
- Quantity
- 16,228 3000 mL bags
- Recall started
- August 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0653-2025
-
Class II Ongoing
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Lots, distribution and details
- Lots / codes
- Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
- Distribution
- U.S. Nationwide
- Quantity
- 26,316 3000 mL bags
- Recall started
- August 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0652-2025
-
Class II Ongoing
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial N…
Reason: cGMP deviations: Temperature excursion during transportation.
Lots, distribution and details
- Product
- Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
- Lots / codes
- Only the following 6 GTN Numbers for Lot # 110459 exp. date 02/28/2027: (01)00307813528104(21)10686040629319 (01)00307813528104(21)10687281435306 (01)00307813528104(21)10687409963168 (01)00307813528104(21)10701200331212 (01)00307813528104(21)10687325644911 (01)00307813528104(21)10687661160169
- Distribution
- Nationwide in the USA
- Quantity
- 6 vials
- 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-0651-2025
-
Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10×10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Lots / codes
- Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 873 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0650-2025
-
Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10×10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pac…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10×10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
- Lots / codes
- Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 1,757 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0649-2025
-
Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10×10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10×10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
- Lots / codes
- Lot: 1022159, exp 12/31/2026; 1023299, exp 03/31/2027; 1024057, Exp 04/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- 1,062 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0648-2025
-
Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5×10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10×10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5×10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10×10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Lots / codes
- Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 2,708 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0647-2025
-
Class II Ongoing
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: C274-000044756, C274-000044757, Exp 8-30-2025; C274-000044832, C274-000044833, Exp 9-4-2025; C274-000044882, C274-000044883, Exp 9-6-2025, C274-000044972, Exp 9-8-2025; C274-000045004, C274-000045005, Exp 9-18-2025 C274-000045108, exp. date 9-13-2025 C274-000045109, exp. date 9-13-2025 C274-000045136, exp. date 9-14-2025 C274-000045137, exp. date 9-14-2025 C274-000045289, exp. date 9-20-2025 C274-000045290, exp. date 9-20-2025 C274-000045350, exp. date 9-22-2025 C274-000045351, exp. date 9-22-2025 C274-000045387, exp. date 9-25-2025 C274-000045388, exp. date 9-25-2025 C274-000045516, exp. date 9-27-2025 C274-000045517, exp. date 9-27-2025 C274-000045586, exp. date 10-2-2025 C274-000045587, exp. date 10-2-2025 C274-000045676, exp. date 10-4-2025 C274-000045677, exp. date 10-4-2025 C274-000045707, exp. date 10-5-2025 C274-000045708, exp. date 10-5-2025 C274-000045754, exp. date 10-9-2025 C274-000045755, exp. date 10-9-2025 C274-000045840, exp. date 10-11-2025 C274-000045841, exp. date 10-11-2025 C274-000046048, exp. date 10-24-2025 C274-000046049, exp. date 10-24-2025 C274-000046095, exp. date 10-25-2025 C274-000046096, exp. date 10-25-2025 C274-000046122, exp. date 10-26-2025 C274-000046123, exp. date 10-26-2025 C274-000046164, exp. date 10-30-2025 C274-000046165, exp. date 10-30-2025 C274-000046191, exp. date 10-31-2025 C274-000046192, exp. date 10-31-2025 C274-000046240, exp. date 11-1-2025 C274-000046241, exp. date 11-1-2025 C274-000046315, exp. date 11-6-2025 C274-000046316, exp. date 11-6-2025 C274-000046345, exp. date 11-7-2025 C274-000046346, exp. date 11-7-2025 C274-000046515, exp. date 11-14-2025 C274-000046516, exp. date 11-14-2025 C274-000046603, exp. date 11-16-2025 C274-000046657, exp. date 11-20-2025 C274-000047136, exp. date 12-12-2025
- Distribution
- USA nationwide.
- Quantity
- 109,320 syringes
- Recall started
- August 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0646-2025
-
Class II Ongoing
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
Reason: Superpotent drug
Lots, distribution and details
- Product
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
- Lots / codes
- Lot #: 24144162, Exp. Date 09/2027
- Distribution
- Nationwide in the USA.
- Quantity
- 2,256 bottles
- Recall started
- August 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0645-2025
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.