Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.
632 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM
cGMP deviations.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15. — Distribution: U.S. Nationwide. — Lots/codes: Lot 020226202150202, Exp Date 05/05/2026. — Status: Ongoing (voluntary: firm initiated)
D-0508-2026 · 50 syringes
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)
Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005 — Distribution: Product was distributed to a single Direct Account with multiple locations across several East Coast states including (Delaware, Pennsylvania, New Jersey, Maryland, New York) — Lots/codes: LOT CODE PP0576D1 BEST BY:02/26/2027 — Status: Terminated (voluntary: firm initiated)
H-0681-2026 · 50 cases
Product contains undeclared milk.
Coconut Drink 1; NET VOLUME: 1L; Ingredients: Coconut water, freshly squeezed coconut gravy, white granulated sugar, emulsion stabilizer [sodium caseinate, mono- and diglycerides fatty acid esters, sucrose fatty acid esters]; Storage Condition: Room temperature; Manufactured in: Hainan, China; imported By: HK HEYTEA FOOD AND BEVERAGE MANAGEMENT LIMITED; For catering establishment; UPC: 673367992785 — Distribution: New York, New Jersey, Massachusetts, Virginia, Maryland, California, Washington, Texas — Lots/codes: Batch Numbers: 2025/03/25 2025/04/06 2025/04/12 2025/08/17 2025/09/04 2025/09/08 2025/09/18 — Status: Ongoing (voluntary: firm initiated)
H-0646-2026 · 12677 cartons
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN. — Status: Ongoing (voluntary: firm initiated)
D-0419-2026 · 88,008 bottles- 100's count
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY. — Status: Ongoing (voluntary: firm initiated)
D-0420-2026 · 58,896 bottles- 100's count
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. . — Status: Ongoing (voluntary: firm initiated)
D-0421-2026 · 28,157 bottles- 100's count
Contains undeclared egg, soy, and hazelnut
Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles — Distribution: Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Hampshire, New J… — Lots/codes: 100 count bottles - UPC: 693465524114,693465000083 Lot: 25E04-A, 25E04-B, 25E04 Expiration date: 05/27 200 count bottles - UPC:693465524213,693465000090 Lot: 25E04-B Expiration date: 05/27 — Status: Ongoing (voluntary: firm initiated)
H-0663-2026 · 11,849 bottles
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10 — Distribution: Nationwide in the USA. — Lots/codes: Batch # FD253967, Exp Date: 06/26/2027 — Status: Ongoing (voluntary: firm initiated)
D-0484-2026 · 4,740 1,000-count bottles.
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1-Gallon and 2-Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid. — Distribution: IL, IN and TX — Lots/codes: Lot Codes: 6 fl oz cups--- 03026, 00226, 05426, 05726 16 fl oz (or pint) -- 33825 32 fl oz-- 33825 1 gallon-- 03026 — Status: Terminated (voluntary: firm initiated)
H-0650-2026 · Total of 1,333 multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail)
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid. — Distribution: IL, IN and TX — Lots/codes: Lot Codes: 6 fl oz cups--- 00226, 03026, 05426, 33825 16 fl oz (or pint) -- 33825 1 gallon--05726 — Status: Terminated (voluntary: firm initiated)
H-0651-2026 · Total of 757 multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail)
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Zarlengo's Double Dark Chocolate Gelato packaged in 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid. — Distribution: IL, IN and TX — Lots/codes: Lot Codes: 6 fl oz cups--- 00226, 03026, 05426, 33825 16 fl oz (or pint) -- 33825 1 gallon--05726 — Status: Terminated (voluntary: firm initiated)
H-0652-2026 · Total of 173 1-gallon bucket/pail
Undeclared allergen (almond).
Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC 8 75343 00001 3. Keep Refrigerated. Made For Einstein Noah Restaurant Group Inc., Lakewood, CO 80228. — Distribution: CA, CO, OR, SC — Lots/codes: Best if Used By: Jul 21 2026 — Status: Terminated (voluntary: firm initiated)
H-0675-2026 · 940 cases (30 units/case)
Product may contain foreign objects, specifically glass.
Alain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars — Distribution: MA — Lots/codes: C250422AT DDM: 04/2028 — Status: Terminated (voluntary: firm initiated)
H-0773-2026 · 1 case (6 jars)
Lack of Assurance of Sterility
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 — Distribution: Nationwide within the United States — Lots/codes: Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M — Status: Ongoing (voluntary: firm initiated)
D-0443-2026 · 720 bottles
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1 — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76252, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)
D-0475-2026 · 24,672 15 g tubes
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2. — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76251, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)
D-0476-2026 · 41,712 30g tubes
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3. — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76250, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)
D-0477-2026 · 2,640 60g tubes
May be temperature abused, which may result in growth of Clostridium botulinum
Crab Cakes various sizes sold to food service — Distribution: NY and NJ — Lots/codes: Production on March 9, 11, 13, 16 & 18 in 2026 Unit Size: Our crabcakes are custom made and go from .5oz up to 5oz per cake 1.5 - Container Description: They are shipped in shrimp boxes that generally weigh between 4-5lbs 1.6 - Total Package Size: They contain from 20 up to 135 crabcakes per box depending on the cake size — Status: Terminated (voluntary: firm initiated)
H-0656-2026 · 39 boxes or approximately 175lbs of crab cakes
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Bombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Spices, Salt, FD&C Tomato Color and Citric Acid; CAUTION: May Contain Traces of Peanuts, Cashews and/or Tree Nuts; Manufactured by Bombay Kitchen Foods Port Washington, NY 11050 — Distribution: NJ — Lots/codes: UPC: 808550100085 — Status: Terminated (voluntary: firm initiated)
H-0669-2026 · 53 cases
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Chana Dal (Split Bengal Gram), Brown Lentils (Masoor), Chickpeas, Rice Flakes, Puffed Rice, Spices, Sugar, Peanuts, Raisins, Yogurt (pasteurized Grade A Milk and Cultures), Green Chilli, Salt, FD&C tomato Color and Citric Acid; CONTAINS: Peanuts, Milk; CAUTION: May Contain Traces of Peanuts, Cashews and/or Tree Nuts; Manufactured by Bombay Kitchen Foods Port Washington, NY 11050 — Distribution: NJ — Lots/codes: UPC: 808550100016 — Status: Terminated (voluntary: firm initiated)
H-0670-2026 · 69 cases
Presence of particulate matter
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. — Distribution: U.S. Nationwide. — Lots/codes: Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028… — Status: Ongoing (voluntary: firm initiated)
D-0447-2026 · 866,570 vials
Presence of particulate matter
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91. — Distribution: U.S. Nationwide. — Lots/codes: Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029 — Status: Ongoing (voluntary: firm initiated)
D-0448-2026 · 306,810 vials
Failed Dissolution Specifications
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61 — Distribution: US Nationwide. — Lots/codes: Lot # N02425, Exp Date: 05/31/2027. — Status: Ongoing (voluntary: firm initiated)
D-0485-2026 · N/A
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.
Booey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Water, Soybeans, Wheat, Salt ***Squid Sauce (Anchovy Extract) ***Sesame Oil***. — Distribution: Distributed in WA. — Lots/codes: None — Status: Terminated (voluntary: firm initiated)
H-0665-2026 · 870 bottles
Undeclared allergen (soy lecithin).
Park St. Deli Macaroni & Cheese, NET WT 20 OZ (1 LB 4 OZ) 567g, product packed in plastic tub and placed into paperboard sleeve. 9/20 oz packages per case. — Distribution: Nationwide — Lots/codes: SUL4839705; SUL4839706; SUL4853771; SUL4853772; SUL4854698; SUL4854700; SUL4854701; SUL4855698; SUL4855699; SUL4855700; SUL4857735; SUL4857736; SUL4857737; SUL4857784; SUL4857785; SUL4866750; SUL4866751; SUL4866752; SUL4866781; SUL4866782; SUL4866783; SUL4866784; SUL4872813; SUL4872814; SUL4872815; SUL4873787; SUL4873788; SUL4886739; SUL4886740; SUL4887698; SUL4887699 — Status: Ongoing (voluntary: firm initiated)
H-0940-2026 · 58,405 cases (9-20 oz packages/case)
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026. — Status: Ongoing (voluntary: firm initiated)
D-0438-2026 · 25,260 bags
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026. — Status: Ongoing (voluntary: firm initiated)
D-0439-2026 · 5140 bags
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026. — Status: Ongoing (voluntary: firm initiated)
D-0440-2026 · 34,260 bags
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026. — Status: Ongoing (voluntary: firm initiated)
D-0441-2026 · 16,130 bags
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026. — Status: Ongoing (voluntary: firm initiated)
D-0442-2026 · 11,680 bags
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
D-0456-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
D-0457-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
D-0458-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
D-0459-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)
D-0460-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085 — Distribution: US Nationwide. — Lots/codes: Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026. — Status: Ongoing (voluntary: firm initiated)
D-0461-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047. — Distribution: US Nationwide. — Lots/codes: Lot# 20240524, Exp Date: 05/24/2026. — Status: Ongoing (voluntary: firm initiated)
D-0462-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030. — Distribution: US Nationwide. — Lots/codes: Lot# 20240730, Exp Date: 07/30/2026. — Status: Ongoing (voluntary: firm initiated)
D-0463-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot# 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
D-0464-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot # 20240524, Exp Date: 05/24/2026; Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
D-0465-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026, Lot # 20241030, Exp Date: 10/30/2026. — Status: Ongoing (voluntary: firm initiated)
D-0466-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
D-0467-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
D-0468-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026; Lot # 20240524, Exp Date: 05/24/2026. — Status: Ongoing (voluntary: firm initiated)
D-0469-2026 · N/A
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)
D-0470-2026 · N/A
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 — Distribution: US Nationwide. — Lots/codes: Lots# H03125, H03225, H03325, Exp Date: 2027/08 — Status: Ongoing (voluntary: firm initiated)
D-0486-2026 · 9384 bottles
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5. — Distribution: Nationwide within the USA — Lots/codes: Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026. — Status: Ongoing (voluntary: firm initiated)
D-0408-2026 · 29,542 bottles
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027. — Status: Ongoing (voluntary: firm initiated)
D-0472-2026 · 124,054 Cartons
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 — Status: Ongoing (voluntary: firm initiated)
D-0473-2026 · 62,136 Cartons
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027. — Status: Ongoing (voluntary: firm initiated)
D-0474-2026 · 113,943 Cartons
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