Arzneimittel & Medikamente Recalls

Pharmaceutical recall notices, chemical impurities, and biological contamination.

Showing 24 of 649 results
PharmaceuticalUKUK

Class 3 Medicines Recall: Bayer Plc, Various Products, EL(26)A/12

Bayer PlcUK
uk-mhraMedicines Recall

Class 3 Medicines Recall: Bayer Plc, Various Products, EL(26)A/12

Bayer Plc is recalling all stock of the products listed in this notification as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy a...

Mar 12, 2026Bayer Plc
PharmaceuticalUKUK

Class 2 Medicines Recall: Rokshaw Limited Trading as Curaleaf Laboratories, Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml), EL(26)A/13

Rokshaw Limited Trading as Curaleaf LaboratoriesUK
uk-mhraMedicines Recall

Class 2 Medicines Recall: Rokshaw Limited Trading as Curaleaf Laboratories, Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml), EL(26)A/13

Curaleaf Laboratories are recalling three batches of Curaleaf Oil [FS] 10mg/ml THC 10mg/ml CBD (30ml) due to low THC content....

Mar 12, 2026Rokshaw Limited Trading as Curaleaf Laboratories
PharmaceuticalUSFDA Drugs

Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02

ACME UNITED CORPORATION
FDA DrugsClass II

Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01

ACME UNITED CORPORATION
FDA DrugsClass II

Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0

Mohamed Hagar
FDA DrugsClass I

Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0

Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).

Mar 11, 2026Mohamed Hagar
PharmaceuticalUSFDA Drugs

Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02

ACME UNITED CORPORATION
FDA DrugsClass II

Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

HTO Nevada Inc. dba Kirkman
FDA DrugsClass II

FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

Stability Data Does Not Support Expiry Date.

Mar 11, 2026HTO Nevada Inc. dba Kirkman
PharmaceuticalUSFDA Drugs

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.

Harbin Jixianglong Biotech Co., Ltd.
FDA DrugsClass II

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

Mar 11, 2026Harbin Jixianglong Biotech Co., Ltd.
PharmaceuticalUSFDA Drugs

Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

Teva Pharmaceuticals USA, Inc
FDA DrugsClass II

Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

Failed Dissolution Specifications

Mar 11, 2026Teva Pharmaceuticals USA, Inc
PharmaceuticalUSFDA Drugs

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.

ACME UNITED CORPORATION
FDA DrugsClass II

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1

ACME UNITED CORPORATION
FDA DrugsClass II

Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06

New Life Pharma LLC
FDA DrugsClass II

Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06

Lack of Assurance of Sterility

Mar 11, 2026New Life Pharma LLC
PharmaceuticalUSFDA Drugs

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17

Cipla USA, Inc.
FDA DrugsClass III

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Mar 11, 2026Cipla USA, Inc.
PharmaceuticalUSFDA Drugs

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

The Harvard Drug Group LLC
FDA DrugsClass II

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

Defective container; inadequately sealed blister packaging.

Mar 11, 2026The Harvard Drug Group LLC
PharmaceuticalUSFDA Drugs

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

ACME UNITED CORPORATION
FDA DrugsClass II

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00

ACME UNITED CORPORATION
FDA DrugsClass II

Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.

ACME UNITED CORPORATION
FDA DrugsClass II

WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China

ANTHONY TRINH, 123Herbals LLC
FDA DrugsClass I

SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

Mar 11, 2026ANTHONY TRINH, 123Herbals LLC
PharmaceuticalUSFDA Drugs

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

Teva Pharmaceuticals USA, Inc
FDA DrugsClass II

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

Failed Dissolution Specifications

Mar 11, 2026Teva Pharmaceuticals USA, Inc
PharmaceuticalUSFDA Drugs

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00

ACME UNITED CORPORATION
FDA DrugsClass II

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.

New Life Pharma LLC
FDA DrugsClass II

Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.

Lack of Assurance of Sterility

Mar 11, 2026New Life Pharma LLC
PharmaceuticalUSFDA Drugs

Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Teva Pharmaceuticals USA, Inc
FDA DrugsClass II

Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Failed Dissolution Specifications

Mar 11, 2026Teva Pharmaceuticals USA, Inc
PharmaceuticalUSFDA Drugs

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.

ACME UNITED CORPORATION
FDA DrugsClass II

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalUSFDA Drugs

Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73

ACME UNITED CORPORATION
FDA DrugsClass II

Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION

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