Lower risk Drug recall · FDA · Published December 26, 2018

Sun Pharmaceutical Loperamide Tablets Recall: 24 vs 12 Caplet Label Mismatch

Sun Pharmaceutical recalls 24-capsule loperamide tablets due to inconsistent labeling between front and side panels showing 24 vs 12 caplets.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0391-2019Drug Sun Pharmaceutical ›

Lower-risk recall

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

Take action

Contact the company

Recalling firmSun Pharmaceutical Industries, Inc.270 Prospect Plains Rd · Cranbury, NJ 08512-3605

✎ GovInfoNow plain-language explainer

Sun Pharmaceutical is recalling 2 mg loperamide tablets that show a mismatch in labeling: the front panel says 24 caplets while the side panel says 12. This could lead to confusion about how many tablets are in the package. Read more at govinfonow.com/recall/39294-sun-pharmaceutical-loperamide-tablets-recall-24-vs-12-caplet-label.

Source Summary by GovInfoNow · govinfonow.com/recall/39294-sun-pharmaceutical-loperamide-tablets-recall-24-vs-12-caplet-label · Updated October 5, 2026 · FDA enforcement record: FDA #D-0391-2019

Cite this page

“Sun Pharmaceutical Loperamide Tablets Recall: 24 vs 12 Caplet Label Mismatch.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39294-sun-pharmaceutical-loperamide-tablets-recall-24-vs-12-caplet-label. Based on FDA recall #D-0391-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0391-2019%22&limit=1).

The FDA announced on 2018-12-26 that Sun Pharmaceutical Industries, Inc. voluntarily recalled Loperamide HCL tablets due to conflicting labeling indicating both 12 and 24 caplets. The recall affects 5,040 cartons distributed in Ohio.

How to tell if you have it

Brand: Sun Pharmaceutical
Product: LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC
Distributor: Drug Mart-Food Fair Medina
UPC: 0 93351 11270 6
NDC#: 53943-123-24
Lot: 2979325
Expiration: 5/5021
Quantity: 5,040 cartons

The hazard

The front panel of the drug product carton indicates 24 caplets, while the side panel indicates 12 caplets. The carton actually contains 24 caplets.

Context

GovInfoNow's records show SUN PHARMACEUTICAL INDUSTRIES INC has 93 other recalls on record since 2013-05-21. Recent brand recalls include a Tretinoin Cream recall on 2026-09-25 for failed impurities and a Carbamazepine Tablets recall on 2026-08-03 for black spots from burnt ingredients. Other recent recalls of similar products include an American Health Packaging Buprenorphine Tablets Recall on 2026-08-19, a Winder Morphine Sulfate Oral Solution Recall on 2025-11-26, and a Greenstone Methylprednisolone Tablets Recall on 2026-01-15.

How to tell if you have this one

Check for the front panel showing 24 caplets and the side panel showing 12 caplets. The product was distributed by Drug Mart-Food Fair Medina in Ohio with UPC 0 93351 11270 6 and NDC 53943-123-24.

Brand
Sun Pharmaceutical
Product
Sun Pharmaceutical Industries, Inc. recalls LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair…
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Labeling
Verify the front panel shows 24 caplets and the side panel shows 12 caplets.

Where it went and when

Where it was distributed

Distributed in Ohio.

FDA distribution: “OH” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Ohio.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Dec 26, 2018Firm started the recall
Jan 23, 2019FDA classified it Class III
Jan 30, 2019Published in FDA’s Enforcement Report
Apr 2, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Sun Pharmaceutical recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/39294-sun-pharmaceutical-loperamide-tablets-recall-24-vs-12-caplet-label">Sun Pharmaceutical Loperamide Tablets Recall: 24 vs 12 Caplet Label Mismatch (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0391-2019 (December 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0391-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.