SigmaPharm Laboratories LLC recalls
Every recall we track for SigmaPharm Laboratories LLC — 5 in all, from 2014–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from SigmaPharm Laboratories LLC peaked in 2021 (4); 4 since 2017.
All FDA recall records for SigmaPharm Laboratories LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 2 | 2 | 4 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
SigmaPharm Laboratories LLC recalls before 2017
Recalls on record by year.
What to do if you have a recalled SigmaPharm Laboratories LLC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All SigmaPharm Laboratories LLC recalls
4 shown- UnratedDrug
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton
SigmaPharm recalls 250g Sodium Phenylbutyrate Powder (Rx only) due to failed impurity tests. Products with specific lot numbers and expiration dates may pose safety risks. Consumers should contact the manufacturer for details.
SigmaPharmSep 21, 2021 - UnratedDrug
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC
SigmaPharm recalls specific batches of Sodium Phenylbutyrate powder (Rx only) due to failed impurities testing. Affected lots expire May 2023-Nov 2023. Consumers should contact the manufacturer for details.
SigmaPharmAug 13, 2021 - Lower riskDrug
SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC
SigmaPharm recalls 5 mg Asenapine Sublingual Tablets due to incorrect flavoring agent. Affected lots expire AUG 2022. No action needed for safe use.
SigmaPharmApr 19, 2021 - Use cautionDrug
SigmaPharm Laboratories LLC recalls Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC
SigmaPharm recalls specific lots of Liothyronine Sodium Tablets, USP 5 mcg due to potential cross-contamination with trace amounts of a previously manufactured product.
SigmaPharm LaboratoriesApr 22, 2014
SigmaPharm Laboratories LLC recall questions
How many recalls has SigmaPharm Laboratories LLC had?
5 recalls from SigmaPharm Laboratories LLC are on record with U.S. safety agencies, from 2014–2021.
What is the most recent SigmaPharm Laboratories LLC recall?
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton, dated Sep 21, 2021. Every SigmaPharm Laboratories LLC recall is listed on this page, newest first.
What should I do if I have a recalled SigmaPharm Laboratories LLC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new SigmaPharm Laboratories LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.