Browse Drug Recalls

180 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 180 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 180 FDA drug recalls in MD.

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DateProductReasonClassFirm
Feb 26, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufacture... Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due... Class III Lupin Pharmaceuticals Inc.
Feb 13, 2019 Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and ... CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... Class III Lupin Pharmaceuticals Inc.
Feb 1, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Man... Failed Impurities/Degradation Specifications: Out of specification test results in related substa... Class III Lupin Pharmaceuticals Inc.
Jan 28, 2019 Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02)... Failed Impurities/Degradation Specifications: OOS results observed in any other individual impuri... Class III Lupin Pharmaceuticals Inc.
Jan 9, 2019 Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lu... CGMP Deviations; presence of extraneous material in the was observed in area that is between the... Class II Lupin Pharmaceuticals Inc.
Jan 7, 2019 Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, ... CGMP Deviation; manufacturing batch record could not be located Class II Lupin Pharmaceuticals Inc.
Jan 2, 2019 Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-7... CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... Class II Lupin Pharmaceuticals Inc.
Jan 2, 2019 Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-7... CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... Class II Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 6818... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 6... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 19, 2018 Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, ... CGMP Deviations Class II Roberts Home Medical LLC
Oct 9, 2018 Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactur... Defective Container: Repetitive complaints received indicating pump not working. Class III Lupin Pharmaceuticals Inc.
Oct 9, 2018 Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
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.
Aug 13, 2018 Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: ... Presence of Foreign Substance: Product complaint was received of metal contaminant observed in on... Class II Lupin Pharmaceuticals Inc.
Jul 26, 2018 Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... Class III Lupin 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.
May 17, 2018 My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen... Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator... Class II Lupin Pharmaceuticals Inc.
May 17, 2018 My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen... Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator... Class II Lupin Pharmaceuticals Inc.
Apr 9, 2018 Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. Class III LEADIANT BIOSCIENCES, INC
Mar 27, 2018 Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL pack... Superpotent Drug Class II Lupin Pharmaceuticals Inc.
Feb 14, 2018 Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. Class III LEADIANT BIOSCIENCES, 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.