Browse Drug Recalls
10 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 10 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 10 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2015 | Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactur... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC ... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) ... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Nov 6, 2013 | Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefill... | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which p... | Class II | GlaxoSmithKline, LLC. |
| Nov 6, 2013 | Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only... | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which p... | Class II | GlaxoSmithKline, LLC. |
| Jul 18, 2013 | TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 C... | Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable... | Class III | GlaxoSmithKline, LLC. |
| Oct 24, 2012 | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 m... | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... | Class III | GlaxoSmithKline, LLC. |
| Oct 24, 2012 | Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation A... | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... | Class III | GlaxoSmithKline, LLC. |
| Oct 8, 2012 | Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusio... | Impurities/Degradation Products: Potential for drug related impurities to exceed the specificatio... | Class II | GlaxoSmithKline, LLC. |
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.