Browse Drug Recalls

29 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 29 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 29 FDA drug recalls.

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DateProductReasonClassFirm
Dec 27, 2022 Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. Class III Jubilant Cadista Pharmaceuticals, Inc.
Jul 18, 2022 Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... Failed dissolution specifications. Class II Jubilant Cadista Pharmaceuticals, Inc.
Jul 18, 2022 Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... Failed Dissolution Specifications Class II Jubilant Cadista Pharmaceuticals, Inc.
Apr 1, 2022 Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Mar 8, 2022 Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle... Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydroc... Class I Jubilant Cadista Pharmaceuticals, Inc.
Aug 20, 2021 Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: ... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 1, 2021 Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Ju... Failed Dissolution Specifications Class II Jubilant Cadista Pharmaceuticals, Inc.
Feb 19, 2021 Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx... Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosi... Class III Jubilant Cadista Pharmaceuticals, Inc.
Nov 6, 2020 clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Man... Failed Tablet/Capsule Specification Class II Jubilant Cadista Pharmaceuticals, Inc.
Oct 26, 2020 Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) bli... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
May 26, 2020 Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... Presence of Foreign Substance visually consistent with the silica granules present in the desicca... Class III Jubilant Cadista Pharmaceuticals, Inc.
Mar 11, 2020 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx ... CGMP Deviations: Presence of dark brown discoloration on edges of tablets Class II Jubilant Cadista Pharmaceuticals, Inc.
Dec 2, 2019 Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufact... Presence of Foreign Substance: Presence of a foreign object in a single tablet. Class II Jubilant Cadista Pharmaceuticals, Inc.
Sep 4, 2019 Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... CGMP Deviation: Presence of dark brown discoloration on edges of tablets. Class II Jubilant Cadista Pharmaceuticals, Inc.
Jul 9, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... Failed dissolution specifications : failed results at the 3-month stability time point. Class I Jubilant Cadista Pharmaceuticals, Inc.
Mar 29, 2019 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on ... Class II Jubilant Cadista Pharmaceuticals, Inc.
Feb 28, 2019 BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... Failed Dissolution Specifications; 9-monthstability timepoint Class III Jubilant Cadista Pharmaceuticals, Inc.
Oct 2, 2018 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets. Class II Jubilant Cadista Pharmaceuticals, Inc.
Aug 27, 2018 MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... Failed Stability Specifications: An out-of-specification result was obtained during 18-month stab... Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 14, 2018 Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jub... Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 14, 2018 Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubi... Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 14, 2018 Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubi... Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 14, 2018 Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jub... Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... Class III Jubilant Cadista Pharmaceuticals, Inc.
May 25, 2018 Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant ... Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a... Class III Jubilant Cadista Pharmaceuticals, Inc.
Oct 30, 2017 Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only,... Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. Class III Jubilant Cadista Pharmaceuticals, Inc.
Jun 13, 2016 Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur... Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is print... Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 8, 2016 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged ... Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 8, 2016 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged ... Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 8, 2016 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged ... Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... Class III Jubilant Cadista Pharmaceuticals, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.