Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mix-Up
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
Compare with the code on your package — it is the most precise check available.
Drug: Sucralfate
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.