Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.
915 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM
potential presence of Salmonella
Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case — Distribution: Nationwide — Lots/codes: BEST BY 08/06/27 — Status: Ongoing (voluntary: firm initiated)
H-0836-2026 · 606 cases
Product may be contaminated with Salmonella.
Stoltzfus Family Farm Sour Cream and Onion cheese curds, 8-ounce — Distribution: NY, PA — Lots/codes: Best by: 03/25/2026, 04/23/2026, 04/29/2026, 05/06/2026 UPC Codes: 8 59166 00201 0 — Status: Ongoing (voluntary: firm initiated)
H-0848-2026 · 403 lbs.
Products were made with recalled California Dairies milk powder due to Salmonella.
Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166. — Distribution: PA, WI — Lots/codes: Lot # / Production Date: 29 JAN 2026 and 12 APR 2026 — Status: Ongoing (voluntary: firm initiated)
H-0850-2026 · 750 - 10 lb. cases
Products were made with recalled California Dairies milk powder due to Salmonella.
Parmesan & Herb Bagel Crisps, Item Number 18139, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166. — Distribution: PA, WI — Lots/codes: Lot # / Production Date: 29 JAN 2026 and 12 APR 2026 — Status: Ongoing (voluntary: firm initiated)
H-0851-2026 · 588 - 10 lb. cases
Products were made with recalled California Dairies milk powder due to Salmonella.
giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt 7.33 oz. Shipping Case: 12 ct - 7.33 oz Bags Net Weight: 5.49 lbs. Legacy Bakehouse, LLC, Waukesha WI 53186. — Distribution: PA, WI — Lots/codes: Shipping Case Lot # 071626 — Status: Ongoing (voluntary: firm initiated)
H-0852-2026 · 224 cases - 7.33 oz/12 ct
Potential contamination with Salmonella
72% CACAO CHOCOLATE WITH DATE SUGAR WAFERS Ingredients: Cacao Beans, Organic Date Powder, Organic Cocoa Powder Net Wt 25lb (11.3kg) Made in the USA GUITTARD CHOCOLATE COMPANY Burlingame, CA 94010 Item: 0568C25 UPC: 00071818367654 — Distribution: Domestic Distribution: OH. Foreign Distribution: N/A. — Lots/codes: Lot code, Best By: 11775A, 12/27/2026; 21775A, 12/27/2026; 31785A, 12/28/2026; 11785A, 12/28/2026; 21785A, 12/28/2026; 22095M, 01/28/2027; 12105M, 01/29/2027; 22105M, 01/29/2027. — Status: Ongoing (voluntary: firm initiated)
H-0861-2026 · 2,857 cases (25 lbs/case)
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.
My Wife's Slaw, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands, MyWifeslaw.web.app, Zanesville, Ohio. Ingredients: Cabbage, Sugar, Vinegar, Mustard, Carrots, Onion, Bell Pepper, Salt, Black Pepper, Cayenne Pepper. — Distribution: Products distributed directly to end consumers in AL, OH, TX, WV. — Lots/codes: No codes applied — Status: Terminated (voluntary: firm initiated)
H-0901-2026 · 10 individual units (TOTAL)
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.
My Wife's Slaw Jalapeno Heat, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands, MyWifeslaw.web.app, Zanesville, Ohio. Ingredients: Cabbage, Sugar, Vinegar, Mustard, Carrots, Onion, Bell Pepper, Salt, Black Pepper, Cayenne Pepper, Jalapenos, Red Pepper Flakes. — Distribution: Products distributed directly to end consumers in AL, OH, TX, WV. — Lots/codes: No codes applied — Status: Terminated (voluntary: firm initiated)
H-0902-2026 · 10 individual units (TOTAL)
Failed Impurities/Degradation Specifications
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. — Status: Ongoing (voluntary: firm initiated)
D-0539-2026 · Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame.
Market of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged into a clear flexible plastic clamshell container. Label has UPC 0 210126 01099 3. Market Central Kitchen 1150 Owen Loop S. Eugene, OR 97402 The Za'atar spice, which contains Sesame Seeds, is mixed with chickpeas and packaged into a 2-oz plastic cup. This 2-oz. cup with chickpeas is then assembled into the finished product: a 9.5oz flexible clear plastic clamshell container of Vegan Kale Caesar Salad. — Distribution: Only in OR state. — Lots/codes: Expiration dates: 4/20/2026 4/21/2026 4/24/2026 4/25/2026 4/27/2026 4/28/2026 5/1/2026 5/2/2026 5/4/2026 5/5/2026 — Status: Terminated (voluntary: firm initiated)
H-0904-2026 · 289 (9.5oz) units
Products were made with recalled California Dairies milk powder due to Salmonella.
White Cheddar Seasoning packed in the following sizes and configurations: 1. Net Wt. 1.2 oz (34g) Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold in a Fireworks Popcorn, Natural American Popcorn Popping & Toppings gift set. Contains: 3 popcorns & 3 popcorns seasonings. 2. Net Wt. 1.6 oz. (45g) UPC 7 36659-26501 8. Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold at West Allis Cheese and Sausage retail store. 3. Net Wt 0.7 oz (19g) Williams Sonoma, Not for Retail Sale. Sold in a Williams Sonoma branded Popcorn Sampler Gift Box. Set includes 2 popcorns, oil, seasoning and salt. — Distribution: MS, WI — Lots/codes: 1. Lot# 088594-5-1 2. Lot# 088594-7-1 3. Lot# 088594-2-1 — Status: Terminated (voluntary: firm initiated)
H-0953-2026 · 1407 jars total
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Coconut, 4 oz (85 g), with UPC 710594511867 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1158-2026 · 368 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Fresa Leche, 4 oz (85 g), with UPC 710594511850 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1159-2026 · 149 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Arroz con Leche, 4 oz (85 g), with UPC 710594511843 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1160-2026 · 216 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1161-2026 · 129 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Guayaba, 1 Bar (81.7 g), with UPC 827912008432 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1162-2026 · 40 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Vainilla, 4 oz (85 g), with UPC 710594511829 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1163-2026 · 144 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Rompope, 4 oz (85 g), with UPC 710594511812 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1164-2026 · 111 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1165-2026 · 121 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Nuez, 1 Bar (81.7 g), with UPC 827912008548 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1166-2026 · 185 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1167-2026 · 140 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Pina Colada, 1 Bar (81.7 g), with UPC 710594511225 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1168-2026 · 150 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Limon, 4 oz (85 g), with UPC 710594511836 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1169-2026 · 170 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Grocella, 1 Bar (81.7 g), with UPC 827912008531 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1170-2026 · 46 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1171-2026 · 167 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Tamarindo, 1 Bar (81.7 g), with UPC 827912008593 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1172-2026 · 129 Cases
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Ice Pop, D'Dioses Nanche, 1 Bar (81.7 g), with UPC 827912008449 — Distribution: Distributed in the following states: NJ, CT, NY, PA. — Lots/codes: 710594511867,710594511850, 710594511560, 827912008456, 8279120084732, 710594511829, 71059511812, 827912008487, 827912008548, 710594511836, 827912008531, 827912008494, 827912008593, 827912008449, 710594511362,710594511225 — Status: Ongoing (voluntary: firm initiated)
H-1173-2026 · 120 cases
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11 — Distribution: USA Nationwide — Lots/codes: Lot#: 1027583, Exp 09/30/2027 — Status: Ongoing (voluntary: firm initiated)
D-0536-2026 · 63,500 tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 — Distribution: USA Nationwide — Lots/codes: Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 — Status: Ongoing (voluntary: firm initiated)
D-0537-2026 · 225,000 tablets
Presence of a Foreign Substance; black particles observed in liquid
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08 — Distribution: OH — Lots/codes: Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026 — Status: Ongoing (voluntary: firm initiated)
D-0549-2026 · 520 syringes
Undeclared allergen ingredient (fish)
...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409 30oz UPC- 8541200411 — Distribution: Product was distributed to locations in California, Texas and Georgia. — Lots/codes: No lot numbers provided. Recall includes all product. — Status: Ongoing (voluntary: firm initiated)
H-0780-2026 · 199,750 units (across 3 different sizes)
Products may be potentially contaminated with Salmonella.
#007560 Fiery Hot Seasoning (Reduced Salt), Net Wt: 25 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094 — Distribution: KS, MN, NY, WI — Lots/codes: Lot: 087861-1-1 — Status: Ongoing (voluntary: firm initiated)
H-0881-2026 · 50 lbs.
Products may be potentially contaminated with Salmonella.
#009530 Ranch Seasoning, Net Wt: 50 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094. — Distribution: KS, MN, NY, WI — Lots/codes: Lot: 088461-1-1 — Status: Ongoing (voluntary: firm initiated)
H-0882-2026 · 4 - 50 lb. boxes
Products may be potentially contaminated with Salmonella.
#007415 Fiery Hot, Net Wt: 25 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094. — Distribution: KS, MN, NY, WI — Lots/codes: Lot: 088393-1-1 — Status: Ongoing (voluntary: firm initiated)
H-0883-2026 · 36 boxes
Products may be potentially contaminated with Salmonella.
Karlsburger Kitchens Garlic N Cheese Topper, Net Wt: 20 oz. (567g). Distributed by: Karlsburger Foods, Inc., Monticello, MN 55362 — Distribution: KS, MN, NY, WI — Lots/codes: Lot: 087534-3-1 and Lot: 088382-4-1 — Status: Ongoing (voluntary: firm initiated)
H-0884-2026 · 168 jars
Products may be potentially contaminated with Salmonella.
#800414/003729Butter Parsley, Net Wt: 50 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094 — Distribution: KS, MN, NY, WI — Lots/codes: Lot: 087735-1-1 — Status: Ongoing (voluntary: firm initiated)
H-0885-2026 · 3 boxes
Products may be potentially contaminated with Salmonella.
Popping Topping, Sour Cream & Onion Flavored Popcorn Seasoning, Net Wt: 1.6oz. UPC 0 31851-01001 6. Distributed By: Butler's Pantry, 1224 Clark St. Watertown, WI 53094. — Distribution: KS, MN, NY, WI — Lots/codes: Lot: 057596 — Status: Ongoing (voluntary: firm initiated)
H-0886-2026 · 782 jars
Products may be potentially contaminated with Salmonella.
#003020 Sour Cream & Onion, Net Wt: 10 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094. — Distribution: KS, MN, NY, WI — Lots/codes: Lot# 087307-2-1 — Status: Ongoing (voluntary: firm initiated)
H-0887-2026 · 5 cases (2 - 10 lb. bags per case)
Products may be potentially contaminated with Salmonella.
#003740 Dill & Garlic Seasoning, Net Wt: 10 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094. — Distribution: KS, MN, NY, WI — Lots/codes: Lot# 087307-1-1 — Status: Ongoing (voluntary: firm initiated)
H-0888-2026 · 5 cases (2 - 10 lb. bags per case)
Products may be potentially contaminated with Salmonella.
#0083004 Ranch Seasoning, Net Wt: 25 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094. — Distribution: KS, MN, NY, WI — Lots/codes: Lot# 087002-2-1 — Status: Ongoing (voluntary: firm initiated)
H-0889-2026 · 4 boxes
Products may be potentially contaminated with Salmonella.
White Cheddar Seasoning packaged in the following sized containers: 1. Net Wt. 1.2 oz (34g) Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold in a Fireworks Popcorn Popping & Toppings gift set. 2. Net Wt. 1.6 oz. (45g) UPC 7 36659-26501 8. Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold at West Allis Cheese and Sausage retail store. 3. Net Wt 0.7 oz (19g) Williams Sonoma, Not for Retail Sale. Sold in a Williams Sonoma branded Popcorn Sampler Gift Box. — Distribution: KS, MN, NY, WI — Lots/codes: 1. Lot# 088594-5-1 2. Lot# 088594-7-1 3. Lot# 088594-2-1 — Status: Ongoing (voluntary: firm initiated)
H-0890-2026 · 5200 jars total
Possible contamination with Cereulide toxin.
a2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g) Intended use: infant formula (0 12 months). Condition: shelf stable product Type of packaging: metal tin with plastic dust cap. Net weight: 31.7oz (900gm). UPC: 813267020335. Firm name listed on label: The a2 Milk Company. 4909 Pearl East Circle, Suite 300 Boulder CO 80301. — Distribution: The recalled product was distributed throughout the United States. — Lots/codes: Lot # 2210321712 with Expiration Date: 01/14/2027, Lot # 2210324609 with Expiration Date 01/21/2027, Lot # 2210269454 with Expiration Date 07/15/2026 — Status: Completed (voluntary: firm initiated)
H-0891-2026 · 51,202 units
The product may contain undeclared allergens (cashews, pistachios), and dried cherries.
SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case. — Distribution: Distributed nationwide in retail stores and through online orders. — Lots/codes: Best if Used By: 2/12/2027 — Status: Ongoing (voluntary: firm initiated)
H-0905-2026 · 24,756 (10-oz pouch) total units
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 — Distribution: TX only — Lots/codes: Lot #: 25530722 — Status: Ongoing (voluntary: firm initiated)
D-0538-2026 · 149 capsules
Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella.
Malazi 100% PURE SUDANESE SESAME Tahina G.W.: 1K.g UPC 6 224011 088244 Produced by: AL-MALAZ COMPANY FOR TRADE AND INDUSTRY Piece No. 110-250 acres area Badr City - Egypt — Distribution: Product was shipped to MI & NC. — Lots/codes: PROD: 31/12/2024 EXP: 30/12/2026 — Status: Ongoing (voluntary: firm initiated)
H-0860-2026 · 11cs/6/ 2lb bottles
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India — Distribution: Nationwide within U.S — Lots/codes: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26. — Status: Ongoing (voluntary: firm initiated)
D-0514-2026 · 312,894 packs
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 — Distribution: Nationwide within U.S — Lots/codes: Lot#: PA07434, Exp. May 2026. — Status: Ongoing (voluntary: firm initiated)
D-0515-2026 · 77,376 packs.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. — Distribution: Nationwide within U.S — Lots/codes: Lot#: PA10734, Exp. Jun 2026. — Status: Ongoing (voluntary: firm initiated)
D-0516-2026 · 117,168 packs
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1). — Distribution: Nationwide within the U.S — Lots/codes: Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026. — Status: Ongoing (voluntary: firm initiated)
D-0544-2026 · 23,880 bottles
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3). — Distribution: Nationwide within the U.S — Lots/codes: Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027. — Status: Ongoing (voluntary: firm initiated)
D-0545-2026 · 10,992 bottles
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