Class II · Moderate risk
Gs Anti Diarrheal Loperamide Caplet 12 Ct Sku 915632 Imodium Ad…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Loperamide HCL Tablets USP (Loperamide Hydrochloride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
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.
What was recalled
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24
Affected NDC
53943-0123-24
Compare with the code on your package — it is the most precise check available.
Drug: Loperamide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Loperamide Hydrochloride NDC 53943-0123 |
2 mg/1 | Tablet Oral |
Discount Drug Mart | OTC |
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0391-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Loperamide recalls
See all
Class II · Moderate risk
Loperamide Hydrochloride capsules
cGMP deviations: Temperature abuse
Class III · Low risk
Imodium Multi-Symptom Relief Caplets
Defective Container; damaged blister units
Other recalls by Sun Pharmaceutical Industries, Inc.
All 2018 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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