Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
1,070 recalls
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Class II Ongoing
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
- Lots / codes
- Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026
- Distribution
- U.S. Nationwide
- Quantity
- —
- Recall started
- September 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0020-2026
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Class II Ongoing
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Lots / codes
- Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July 2026
- Distribution
- U.S. Nationwide
- Quantity
- —
- Recall started
- September 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0019-2026
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Class II Ongoing
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Asc…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Lots / codes
- Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026
- Distribution
- U.S. Nationwide
- Quantity
- —
- Recall started
- September 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0018-2026
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Class II Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, D…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Lots / codes
- Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026
- Distribution
- U.S. Nationwide
- Quantity
- 141,984 bottles
- Recall started
- September 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0017-2026
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Class II Ongoing
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.
Reason: Discoloration
Lots, distribution and details
- Lots / codes
- Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
- Distribution
- USA Nationwide
- Quantity
- 13080 bottles
- Recall started
- October 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0016-2026
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Class II Ongoing
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Reason: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Lots, distribution and details
- Lots / codes
- Lot #: P24ZLK1, Exp 5/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 4,680 500-count bottles
- Recall started
- September 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0014-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
- Lots / codes
- Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
- Distribution
- Nationwide
- Quantity
- 1394 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0013-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
- Lots / codes
- Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
- Distribution
- Nationwide
- Quantity
- 866 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0012-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
- Lots / codes
- Lots N02009 & N02026, exp. date 02/28/2026
- Distribution
- Nationwide
- Quantity
- 506 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0011-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)003090471306…
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
- Lots / codes
- Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
- Distribution
- Nationwide
- Quantity
- 1256 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0010-2026
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Class II Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5×10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lots, distribution and details
- Lots / codes
- Lots N01943 and Lot N02025, exp. date 02/28/2026
- Distribution
- Nationwide
- Quantity
- 2064 blister packs
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0009-2026
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Class II Ongoing
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598…
Reason: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Lots, distribution and details
- Product
- Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
- Lots / codes
- Lot # K250048
- Distribution
- Nationwide within the USA.
- Quantity
- 571 vials
- Recall started
- September 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0008-2026
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Class II Ongoing
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots, distribution and details
- Lots / codes
- Lot#: E409309, Exp 12/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 600 30-count bottles
- Recall started
- September 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0002-2026
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Class II Ongoing
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots, distribution and details
- Lots / codes
- Lot#: E409308, Exp 12/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 912 30-count bottles
- Recall started
- September 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0001-2026
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Class III Ongoing
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
Reason: Cross Contamination with Other Products.
Lots, distribution and details
- Product
- TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
- Lots / codes
- Lot 0662036; Exp Date 06/19/2027
- Distribution
- US Nationwide.
- Quantity
- 60 bottles
- Recall started
- August 25, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0661-2025
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Class III Ongoing
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
Reason: Cross Contamination with Other Products.
Lots, distribution and details
- Product
- Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
- Lots / codes
- Lot 0662036; Exp. Date 06/19/2027
- Distribution
- US Nationwide.
- Quantity
- 1860 bottles
- Recall started
- August 25, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0660-2025
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Class II Ongoing
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Reason: Failed Impurity/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot E309377, Exp 11/30/2025
- Distribution
- U.S. Nationwide
- Quantity
- 4440 bottles
- Recall started
- September 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0657-2025
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Class II Ongoing
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason: Failed Impurity/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot E309376; Exp 11/30/2025
- Distribution
- U.S. Nationwide
- Quantity
- 4344 bottles
- Recall started
- September 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0656-2025
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Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10×10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Lots / codes
- Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 873 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0650-2025
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Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10×10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pac…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10×10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
- Lots / codes
- Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 1,757 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0649-2025
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Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10×10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10×10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
- Lots / codes
- Lot: 1022159, exp 12/31/2026; 1023299, exp 03/31/2027; 1024057, Exp 04/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- 1,062 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0648-2025
-
Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5×10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10×10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5×10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10×10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Lots / codes
- Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 2,708 cartons
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0647-2025
-
Class II Ongoing
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
Reason: Superpotent drug
Lots, distribution and details
- Product
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
- Lots / codes
- Lot #: 24144162, Exp. Date 09/2027
- Distribution
- Nationwide in the USA.
- Quantity
- 2,256 bottles
- Recall started
- August 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0645-2025
-
Class II Completed
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 05…
Reason: Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Lots, distribution and details
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.
- Lots / codes
- Lot#: 25283185A. Expiry: 02/28/2027
- Distribution
- OH
- Quantity
- 4,848 bottles
- Recall started
- August 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0642-2025
-
Class II Ongoing
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace &…
Reason: Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Lots, distribution and details
- Product
- Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
- Lots / codes
- Lot #s: A2453, exp 11/30/2026; A2454, exp 12/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 44,497 tubes
- Recall started
- August 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0641-2025
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.