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Week of Apr 13, 2026

31

Apr 15, 2026recall91d agoFresenius Kabi USA, LLC recall (Cls II)Fresenius Kabi USA LLC

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoViatris, Inc. recall (Cls II)Viatris Inc

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91 — Reason: Failed Dissolution Specifications — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoPreferred Pharmaceuticals, Inc. recall (Cls II)InMed Pharmaceuticals Inc.

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoFagron Compounding Services recall (Cls II)Baxter Healthcare Corp

norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02 — Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoFresenius Kabi USA, LLC recall (Cls II)Fresenius Kabi USA LLC

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoFresenius Kabi USA, LLC recall (Cls II)Fresenius Kabi USA LLC

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoFresenius Kabi USA, LLC recall (Cls II)Fresenius Kabi USA LLC

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack). — Reason: Superpotent and Subpotent — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoFagron Compounding Services recall (Cls II)Revalesio Corp

Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01 — Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoGE Healthcare Ireland Limited recall (Cls II)Amneal Pharmaceuticals, Inc.

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63. — Reason: Presence of particulate matter — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack). — Reason: Superpotent and Subpotent — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoFresenius Kabi USA, LLC recall (Cls II)Fresenius Kabi USA LLC

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Apr 15, 2026recall91d agoCipla USA, Inc. recall (Cls II)Cipla USA Inc

Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 — Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. — Status: Ongoing

full page →fda recalls ↗

04/16/2026recall90d agoLoard’s recall: Food & Beverages, Allergens, Ice Cream/Frozen Dairy

Ice Cream

full page →fda recalls ↗

Apr 16, 2026approval90d agoBRIMONIDINE TARTRATE — FDA approvalLumify

Sponsor: MANKIND PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Lumify →fda approvals ↗

Apr 16, 2026approval90d agoSELEXIPAG — FDA approvalSELEXIPAG

Sponsor: RK PHARMA. Form: TABLET. Route: ORAL

full page →SELEXIPAG →fda approvals ↗

Apr 16, 2026approval90d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗

04/17/2026recall89d agoBreeder’s Edge, Shelter’s Choice recall: Animal & Veterinary, Food & Beverages

Canine milk replacer

full page →fda recalls ↗

Apr 17, 2026approval89d agoSODIUM ACETATE — FDA approvalSODIUM ACETATE

Sponsor: EXTROVIS. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM ACETATE →fda approvals ↗

Apr 17, 2026approval89d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval89d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval89d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval89d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval89d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: QUAGEN. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Apr 17, 2026approval89d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Apr 17, 2026approval89d agoCALCIPOTRIENE — FDA approvalPrasco LLC

Sponsor: GLENMARK SPECLT. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Apr 17, 2026approval89d agoESOMEPRAZOLE MAGNESIUM — FDA approvalesomeprazole magnesium DR

Sponsor: MARKSANS PHARMA. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →esomeprazole magnesium DR →fda approvals ↗

Apr 17, 2026approval89d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval89d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval89d agoTETRACYCLINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals of New York LLC

Sponsor: IMPAX LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Apr 17, 2026approval89d agoTETRACYCLINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals of New York LLC

Sponsor: IMPAX LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Apr 20, 2026

5

04/20/2026recall86d agoAligned Medical Angio Pack recall: Medical Devices

Angio Packs (AMS6908E and AMS6908F)

full page →fda recalls ↗

Apr 20, 2026approval

Week of Apr 27, 2026

10

Apr 27, 2026pdufa79d agoRegeneron Pharmaceuticals Inc — dupilumab (PDUFA)dupilumab

Therapy area: Dermatology. Indication: Chronic Urticaria

full page →dupilumab →source: globaldata

Apr 28, 2026pdufa

Week of Jun 1, 2026

4

Jun 1, 2026pdufa44d agoTest PDUFA

No description on file. Bork keeps sniffing.

full page →source: test

Jun 1, 2026pdufa44d ago

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