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Week of Jul 21, 2025

29

Jul 21, 2025approval387d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Jul 21, 2025approval387d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Jul 21, 2025approval387d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Jul 21, 2025approval387d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Jul 21, 2025approval387d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Jul 21, 2025approval387d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Jul 22, 2025approval386d agoXYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) — FDA approvalSanofi

Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jul 23, 2025approval385d agoOTEZLA (APREMILAST) — FDA approvalapremilast

Sponsor: AMGEN INC. Form: TABLET. Route: ORAL

full page →apremilast →fda approvals ↗

Jul 23, 2025recall385d agoLupin Pharmaceuticals Inc. recall (Cls II)LB PHARMACEUTICALS INC

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01 — Reason: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg. — Status: Ongoing

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Jul 23, 2025recall385d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing

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Jul 23, 2025recall385d agoCentral Admixture Pharmacy Services, Inc (CAPS) Los Angeles recall (Cls II)

PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870. — Reason: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented. — Status: Ongoing

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Jul 23, 2025recall385d agoAscend Laboratories, LLC recall (Cls II)Ascend Laboratories Ltd

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18 — Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. — Status: Ongoing

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Jul 23, 2025recall385d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing

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Jul 23, 2025recall385d agoQualgen, LLC recall (Cls III)Transdermal Delivery Solutions Corp

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01 — Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. — Status: Ongoing

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Jul 23, 2025recall385d agoDr. Reddy's Laboratories, Inc. recall (Cls II)DR REDDYS LABORATORIES LTD

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10 — Reason: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. — Status: Ongoing

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Jul 23, 2025recall385d agoA.P. Deauville, LLC recall (Cls II)

Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313 — Reason: CGMP Deviations — Status: Ongoing

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Jul 23, 2025recall385d agoSUN PHARMACEUTICAL INDUSTRIES INC recall (Cls II)TEVA PHARMACEUTICAL INDUSTRIES LTD

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88 — Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH). — Status: Ongoing

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Jul 23, 2025recall385d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing

full page →fda recalls ↗

Jul 23, 2025recall385d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing

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Jul 23, 2025recall385d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing

full page →fda recalls ↗

Jul 23, 2025recall385d agoA.P. Deauville, LLC recall (Cls II)

Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Jul 23, 2025recall385d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing

full page →fda recalls ↗

Jul 23, 2025recall385d agoA.P. Deauville, LLC recall (Cls II)

Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Jul 23, 2025recall385d agoAscend Laboratories, LLC recall (Cls II)Ascend Laboratories Ltd

Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18 — Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. — Status: Ongoing

full page →fda recalls ↗

Jul 23, 2025recall385d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing

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Jul 24, 2025approval384d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

Jul 24, 2025approval384d agoHALOPERIDOL DECANOATE — FDA approvalHALOPERIDOL DECANOATE

Sponsor: MANKIND PHARMA. Form: INJECTABLE. Route: INJECTION

full page →HALOPERIDOL DECANOATE →fda approvals ↗

Jul 25, 2025approval383d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: ALEMBIC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Jul 25, 2025approval383d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INTRAVENOUS

full page →IBANDRONATE SODIUM →fda approvals ↗

Week of Jul 28, 2025

21

Jul 28, 2025approval380d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jul 29, 2025approval

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